Enfamil is one of the most popular formula brands, but are there recalls for this brand? Is it safe and healthy for your baby? Which products have been included in Enfamil formula recalls, and what should you do if you bought these items?
Finding the best formula for your baby can be a big challenge. Aside from checking the ingredients and nutritional values of these infant formula products, you should also watch for product recalls.
If you’re searching for a new formula for your baby, you can find many that have compositions similar to breast milk.
You might feel secure in choosing your baby’s formula from well-known brand names such as Enfamil.
Finding Alternatives To Recalled Infant Formulas
The massive Similac recall early this year, coupled with the other issues hounding suppliers (e.g., logistics issues amid the pandemic), led to a formula crisis in the US.
To date, many parents face difficulties in finding infant formulas because most of the store shelves are empty or their preferred brands are unavailable.
Babies without metabolic issues and those who don’t need specialized formulas can try the following US brands with their doctor’s approval:
- Bobbie Organic Infant Formula
- ByHeart Baby Formula
- Serenity Kids A2 Toddler Formula (Use our code MHC for 15% off first-time orders, too!)
*Check out our interviews with Serenity Kids founders on their toddler formula, and their baby food pouches.
We also recommend the following European formulas if you’re searching for the best organic baby formula options:
- Hipp Dutch Combiotic Formula
- Holle Organic (Bio)
However, please make sure to consult your pediatrician before changing your baby’s formula, even amid the shortage. Many European formulas don’t have FDA approval. Still, many parents prefer them over US brands.
Does Enfamil Have A Recall?
Yes. Enfamil has had some formula recalls (plus some tampering issues) in the previous years.
Drinking or ingesting contaminated products can lead to gastrointestinal issues, other health problems, or even death in severe cases. That’s why it’s always important to watch out for formula recalls and safety issue warnings or news.
The following are the formula recalls and tampering issues for Enfamil:
Enfamil ProSobee Recall (2023)
Update: February 21, 2023
Reason For The ProSobee Recall
Reckitt voluntarily recalled two batches of ProSobee Simply Plant-Based Infant Formula (12.9 oz) on February 20, 2023, over possible cross-contamination with Cronobacter sakazakii, a potentially deadly bacteria. (1)
Approximately 145,000 cans are affected by this recall. (1)
Reckitt clarifies that only these select ProSobee Simply Plant-Based Infant Formula batches are included in the recall. No other Reckitt products or ProSobee batches are included. (1)
According to the recall advisory, Cronobacter sakazakii can cause the following possibly life-threatening conditions: (1)
- Meningitis (inflammation of the brain’s lining)
- Sepsis (bacteria in the blood)
Symptoms of these potentially deadly conditions include: (1)
- Poor feeding
- Temperature changes
- Abnormal movements
- Grunting breaths
- Jaundice (yellowing skin and whites of the eyes)
How To Identify The Affected Products
Find the lot numbers printed on the bottom of the can to check if your products are included in the recall.
The recalled products have a UPC (Universal Product Code) of 300871214415 and a “Use By Date” of “1 Mar 2024.” These below to the following batches: (1)
The affected ProSobee products were manufactured between August 2022 and September 2022 and were sold through retail stores in the following areas: (1)
- Puerto Rico
Reported Injuries Or Illnesses
According to the recall advisory, no injuries, illnesses, or adverse reactions have been reported concerning this ProSobee recall. (1)
Results Of Product Testing
Reckitt also explains in the recall advisory that all the distributed products had undergone extensive testing and tested negative for the bacteria. (1)
However, they recalled these batches out of an abundance of caution over the suspected cross-contamination with the deadly bacteria. (1)
The company explains that they have taken the extraordinary measure of recalling the formulas because of their commitment to the highest level of safety and quality. Although the recall affected around 145,000 cans, none of these recalled products tested positive for the contaminants. (1)
Reckitt said that they identified the root cause of the isolated situation as material from a third-party supplier after a thorough investigation of the incident. (1)
They assure customers that all appropriate corrective actions have already been taken to ensure product safety. This includes no longer sourcing the affected material from the supplier in question. (1)
What To Do If You Have These Recalled ProSobee Products
Immediately stop using the affected products. You can dispose of the recalled ProSobee formulas or return the can to your place of purchase to receive a full refund. (1)
You can also contact Reckitt through the following channels to help verify whether your product is included in the recall or to get answers to other concerns: (1)
- Phone: 800-479-0551; the hotline is open 24/7
- Email: [emailprotected]
Enfamil Powder Formula Tampering (2019)
One of the most recent issues involving Enfamil didn’t result in a formula recall. But many parents expressed concern that it may have affected several products from the brand.
Ashley Frydrych bought two tubs of an Enfamil baby formula from a Publix Super Market in Tampa Bay, Fla, on June 1, 2019. While the first one was fine, she noticed that the second container was weird. (2)(3)
At first, she thought that the contents of the second container didn’t smell or look like the regular formula she buys for her baby because the brand had just changed its formulation. (2)
She prepared a bottle, but her baby refused to drink it. (2)
“I tried to feed him at 11 and he didn’t take the bottle. I thought he was full. I tried to feed him again at 3 a.m. He didn’t take the bottle, I thought maybe his stomach hurt,” Frydrych explained. (2)
The following morning, she continued to use the formula, but her husband noticed that the contents immediately separated. The powdered contents settled at the bottom while the water was on top. (2)(3)
Upon checking the container, they were surprised to find that the contents smelled and looked more like flour than baby formula. (2)
Her husband tasted the content and confirmed that it was flour, Frydrych told news station WFTS. (2)(3)
“Initially I was really upset at myself because I noticed that it was different but we disregarded it. I didn’t trust my instincts and even my husband didn’t initially either. The formula was in the container without the pouch.
It’s a child’s formula. It’s their lifeline, so why would you tamper with that? The real worry for me, what if it was worse? What if it was a cleaner? What if it was an allergic reaction?”
Concerned that other formulas may have been tampered with as well, Frydrych immediately reported it to Publix. The store quickly took action.
The supermarket released the following statement: (2)
“Food safety is our top priority. The incident was reported to the FDA for investigation. We checked the other lot and date codes for the remaining product, and they were all formula.”
Frydrych also called out Enfamil, asking the company to change their packaging to avoid similar incidents in the future. (2)
In response, Enfamil assured its customers that they are confident about the safety of their products and their long history of quality.
Enfamil released the following statement: (2)
“We encourage consumer feedback that we can share with our team who are continuously looking at ways to innovate our products and packaging.
Importantly, we want parents to know that we take any potential tampering issue very seriously.
We make all of our packaging both tamper-resistant and tamper-evident and we highlight with retail customers the liberal terms of our returns policy designed to ensure that any product returned to a merchant does not make its way back to the shelf or is not otherwise made available for purchase.
We encourage consumers to check the appearance of the package, the label and the product—even differences that may be minor could be meaningful.
If a consumer is uncomfortable using a product they have purchased, they are welcome to call us 1-800-BABY123.”
After conducting separate investigations, both Publix and Enfamil assured customers that this was considered an isolated incident. So, no recall was issued on the formula. (2)(3)
CVS Recall Of Enfamil Formulas (2018)
In 2018, CVS temporarily recalled all Enfamil formulas from stores across the country after one mom, Alison Denning, purchased a tampered container from a CVS outlet in Oldsmar, Florida. (2)(4)
According to Denning, the protective seal on the lid looked intact, but she was surprised when the interior seal was broken. Instead of formula, the contents smelled like baking flour. (2)(4)
Just to make sure, she purchased another formula to compare the first one’s contents. (5)
She explained that the contents of the second formula had a slightly yellowish color, were harder to pack, and looked a little more grainy than the first one she got. It confirmed her suspicion that the first package didn’t contain the formula. (2)
So, she reported the issue to CVS. The store offered to refund her purchase, but Denning also informed Enfamil about the safety issue.
Enfamil manufacturer Mead Johnson sent her a shipping box so they could test the product.
Even before Mead Johnson tested the possibly tampered formula, CVS Pharmacy issued a temporary recall of all Enfamil and got the rest of their stocks off the shelves. (4)
CVS announced: (4)
“The health and safety of our customers is our highest priority and we have robust quality assurance policies and procedures in place to ensure the quality and safety of the products we sell.
We take our customer’s report of suspected tampering of Enfamil purchased at our Oldsmar store seriously. We will be contacting the supplier, and as a matter of precaution we have removed all Enfamil products from this store pending the outcome of our investigation.”
After completing their investigation, CVS and Mead Johnson declared that it was an isolated incident. (4)
No official Enfamil recall was issued. But the company encourages anyone purchasing any of its products to check the package appearance because even differences that might look minor could be hiding a safety or tampering issue. (6)
Enfamil assures customers that their products are safe but welcomes calls to their hotline (1-800-BABY123) from anyone who thinks their formula might have been tampered with. (6)
Possible Product Tampering of Enfamil AR (2018)
Chelsea Bellinger of Buckeye, Arizona, believes that the Enfamil AR formula she bought from a nearby Walmart in Arizona might have been tampered with. (5)
According to Bellinger, her husband had prepared several formula bottles for their baby and put them in the fridge before going to bed.
Early the following morning, she noticed that the powder contents had settled in all the bottles her husband had prepared. The liquid and solid parts were completely separated. (5)
At first, she thought that her husband just didn’t shake the bottles properly when he prepared them. But she was surprised when the powdered contents still didn’t dissolve when she shook the bottles. (5)
So, she decided to heat the baby bottles but realized the consistency didn’t look right. Upon checking, she saw that the bottles had clumpy solids at the bottom. She dumped everything in the sink. (5)
She also checked the powder in the container. The consistency and color were different from what she was used to seeing. But she wasn’t sure what powder might have been used to replace the formula. (5)
Bellinger reported the issue to Walmart. (5)
A spokesperson for the company explained that they reviewed security footage at the store and conducted an internal review to determine whether the possible tampering happened there. (7)
It was declared as an isolated incident. Neither Walmart nor Enfamil issued a recall on relevant products relating to Bellinger’s concern. (5)
Enfamil encouraged its customers to check the packaging of any formula or baby product they buy for signs of tampering in response to the incident. They are encouraged to call the company hotline at 1-800-BABY123 if they have any questions. (5)
Store Recall of Enfamil Newborn (2011)
Enfamil Newborn stocks were pulled out from Supervalu, Walgreen Co, Kroger, and Walmart stores in 2011, over reports that it can cause a rare bacterial infection. (8)
Avery Cornett, a 10-day-old infant in Missouri, reportedly died after drinking Enfamil Premium Newborn from lot number ZP1K7G. (8)
Initial investigations showed that Cronobacter sakazakii, a deadly bacteria, caused the death. (8)
But Mead Johnson assured customers that their products are safe in a written statement:
“We are confident that all our products are safe and nutritious when prepared, stored and used as instructed on the label.” (9)
During the investigation, the situation appears to have become worse for the company:
- While tests were being taken from the late baby’s home and in company facilities, another infant reportedly died after allegedly drinking the formula. (8)(9)
- Two other babies in Illinois and Oklahoma have also been infected, but they both recovered. (8)(9)
The infant deaths angered many parents who have been trusting Enfamil products. Sales plummeted as furious parents boycotted the brand. (8)
Pending the full investigation results, several retailers recalled Enfamil Premium Newborn products or pulled out stocks from their shelves.
Walmart spokeswoman Dianna Gee issued the following statement:
“As a precautionary measure, we made a company decision to remove the specific lot of the product from our store shelves nationwide. We’re not saying the product’s unsafe.”
But after numerous tests, the FDA (Food and Drug Administration) and CDC (Centers for Disease Control and Prevention) cleared Mead Johnson Nutrition Co. and declared the products safe.
According to a joint statement from the two government agencies, their tests showed that unopened cans of Enfamil Newborn powdered formula didn’t have Cronobacter. (8)
The agencies also revealed that they found Cronobacter in the following samples: (8)
- An open container of infant formula
- An open bottle of nursery water
- Prepared infant formula
Because the unopened formulas have tested negative for the deadly pathogen, the agencies are unsure how the contamination occurred. But said that it must have happened after the packages had been opened. (8)
So, even if the separate incidents involved the same formula, the agencies declared that there was no evidence that these infections were related. (8)
“There is currently no evidence to conclude that the infant formula or nursery water was contaminated during manufacturing or shipping.
Parents may continue to use powdered infant formula, following the manufacturer’s directions on the printed label.”
No product recall was issued by Mead Johnson or the FDA over the issue. (8)
Mead Johnson’s general manager for North America, Tim Brown, issued the following statement afterward:
“We’re pleased with the FDA and CDC testing, which should reassure consumers, healthcare professionals and retailers everywhere about the safety and quality of our products.” (8)
Mead Johnson, FDA, and CDC reminded parents to follow safe practices and procedures in preparing and storing baby formula to help avoid possible contamination. (8)(9)
Enfamil Gentlease Recall (2006)
In 2006, Mead Johnson recalled Gentlease powdered infant formula from lot number BMJ19, with a “best before date” code of “1 Jul 07”. The affected products may contain metal particles of up to 2.7 mm in size. (10)
According to the recall advisory, in the rare instance that the formula was inhaled by the baby and reached the lungs, the metal particles can cause serious risks to the baby’s respiratory system and throat. (10)
Injuries or symptoms associated with this problem are likely to show up within four hours: (10)
- Breathing difficulties
- Swallowing difficulties
Consumers were advised to check the embossed lot number and expiration date at the bottom of the can. Those affected by the recall should immediately stop using the product and call Mead Johnson at 888-587-7275 for further assistance. (10)
Mead Johnson announced that around 41,464 cans from lot number BMJ19 had been distributed through retail stores across the US starting December 16, 2005. Thankfully, no illnesses or health incidents have been reported. (10)
EnfaCare LIPIL Recall (2004)
Mead Johnson recalled 505 cases of EnfaCare LIPIL for possible Enterobacter sakazakii contamination. (11)
According to the recall advisory, the pathogen may cause the following deadly conditions in newborns, particularly infants with weakened immune systems or premature babies: (11)
- Sepsis (bacteria in the blood)
- Meningitis (inflammation of the brain’s lining)
- Necrotizing enterocolitis (a severe intestinal infection)
The recall alarmed many parents because EnfaCare LIPIL is especially formulated for premature babies and newborns with special dietary requirements. (11)
It affected lot code BME01 with an expiration date code of “1JAN04.” No other lots or products were affected by this recall, and no illnesses were reported. (11)
Customers who purchased this formula were told to call Mead Johnson Consumer Resource Center at 888-587-7275 for milk powder replacement. (11)
Enfamil Nutramigen Recall (2001)
In 2001, Mead Johnson Nutritionals recalled 4.6 million cans of Enfamil Nutramigen ready-to-use and powder formula due to incorrect preparation instructions written in Spanish. (12)
Following these incorrect instructions can lead to serious health problems, especially if the formula has been consumed for several days: (12)(13)
- Irregular heartbeat
- Possibly even death
Babies who are already ill or living in hot climates have a greater risk of experiencing potentially fatal complications. (13)
This formula was distributed in the US, Guam, Puerto Rico, and the Dominican Republic. (13)
This recall involved 3.7 million cans of powder formula (16-ounce) with the following lot codes: (12)
It also affected 930,000 cans of the ready-to-use version (32-ounce) with these lot codes: (12)
In some places, retailers were allowed to continue selling the formula. Still, the correct preparation instructions should be added as tear-off sheets that the customers could immediately see. (13)
Baby Formula Shortage 2022
The massive Similac recall in February 2022 worsened the baby formula shortage affecting the US since 2021.
According to research firm Datasembly, as much as 30% of popular infant formula brands are sold out in the US, with some states like Minnesota being the highest hit at 54% (out-of-stock percentage). (14)
A spokesperson from Enfamil maker Reckitt Benckiser Group PLC announced that the company had increased production. They now ship out 30% more of what they usually produce to help address the shortage. (15)
The company explained that the shortage was affected by the sudden increase in demand, much more than the baby formula industry anticipated. According to Reckitt Benckiser, sales are up by 17%, more than double the predicted birth rates and other indicators. (15)
On April 29, 2022, Abbott Nutrition announced that they’re releasing limited quantities of certain metabolic nutrition formulas at the FDA’s request. These include Similac PM 60/40, Calcilo XD, Ketonex 1 & 2, Glutarex 1 & 2, and Propimex 1 & 2. (16)
The company clarified that these products weren’t part of the recalled lots. All have been tested to comply with product release requirements. (16)
However, Abbott isn’t releasing Similac, Alimentum, and EleCare powder formulas yet (these products were voluntarily recalled in February). So, releasing these metabolic products isn’t expected to solve the ongoing formula shortage. (17)
Baby Formula Shortage (Updates)
FDA Official Resigns Over Formula Crisis
Update: January 26, 2023
FDA deputy commissioner Frank Yiannas, head of the Office of Food Policy and Response, resigns from his post (effective on February 24) over criticism of how the agency handled the on-going formula shortage. (18)
He claims that the food program’s “decentralized structure,” something he inherited, hampers their function, and prevents them from working as an integrated team or protecting the public. (18)
His resignation came a month after an independent reviewer, requested by FDA Commissioner Robert Califf, recommended: (18)
- Reorganization of the FDA’s food program
- Getting “a strong leader” who can handle or limit internal conflicts
Abbott Under Criminal Investigation By US Justice Department
Update: January 24, 2023
Abbott is reportedly under criminal investigation by the US Justice Department regarding their possible role in the formula shortage that continues to affect the US, over a year after it was first announced. (19)
The shortage affected countless babies, many of whom relied on specialty formulas only sold by Abbott. (19)
The Justice Department’s consumer protection branch will investigate Abbott’s liability in the shortage because: (19)
- The company’s shutdown lasted from February to June 2022
- Possibly millions of cans were pulled off the market during the massive recall
Abbott says that they’re “cooperating fully” with the Justice Department’s investigation, according to the company’s spokesperson, Scott Stoffel. (19)
FDA (Food and Drug Administration) investigations revealed different safety violations and lapses at the company’s formula manufacturing facility, including: (19)
- Lax safety protocols
- Bacterial contamination on different occasions
Reckitt Benckiser Expects Formula Shortage To Continue Until Spring
Update: December 4, 2022
The formula shortage crisis persists in the US a year after it began, despite efforts by formula makers to ramp up productions and the government’s strategies to increase supplies by flying formula from across the world. (20)
Yet, according to Enfamil maker Reckitt Benckiser, things aren’t going to be any better soon. The company expects the crisis to continue until spring. (20)
Now holding the US’ top spot as the largest formula supplier (previously held by the trouble-hounded Similac), Reckitt Benckiser has ramped up production by operating formula factories 24/7. However, formula supplies remain low on the market due to the higher demand. (20)
Abbott Plant Reopens After Flooding
Update: July 11, 2022
The Abbott plant that shut down due to massive floods in Sturgis, Michigan, has finally reopened again after three weeks. The plant restarted EleCare production shortly after reopening on July 1, 2022, and will soon make specialty and metabolic formulas. (21)
Overseas Formulas Beyond Shortage
To prevent the crisis from happening again, the FDA plans to allow overseas formula importation from temporary importers to continue shipping beyond the shortage. (22)
The official guidance will be released sometime in September to detail how the companies could meet the FDA’s requirements so they can continue supplying formulas beyond mid-November. (22)
FDA Receives New Report Of Possible Formula-related Infant Death
Update: June 22, 2022
On June 10, the FDA received a report that an infant died in January, possibly due to consumption of Abbott Nutrition formula. (23)
The federal agency launched an investigation over the baby’s death. (23)
US To Import Baby Formula From Mexico
Operation Fly Formula continues to bring more formulas from manufacturing plants across the world whose products meet US standards. (24)
Its tenth mission will bring Gerber Good Start Gentle infant formula from Mexico to Fort Worth, Texas starting on June 24. This particular mission will fly approximately 1 million pounds of formula, which is equivalent to around 16 million 8-oz bottles. (24)
Formulas Arrive From Around The World
Update: June 20, 2022
After President Joe Biden announced “Operation Fly Formula,” the program has facilitated the fast shipment of formulas from across the world, helping solve the US formula shortage.
Formulas shipped in the middle of June:
- 44,000 pounds (equivalent to around 548,000 eight-ounce bottles) of Nestlé Health Science Alfamino and Alfamino Junior (specialty infant formulas) arrived from Switzerland at the Louisville International Airport (25)
- 200,000 8-ounce bottles of Kendamil at Dulles International Airport in Virginia from the United Kingdom (26)
- 95,000 cans (380,000 lbs equivalent to approximately 4 million eight-ounce bottles) of Bubs Australia baby formula arrived in LAX for Albertsons Companies, Walmart, and The Kroger Company from Australia (25)(27)
More formulas expected to arrive by the end of June or starting in July:
- 750,000 cans of Danone formula (Aptamil First Infant Milk Stage 1) equivalent to 19 million 8-ounce bottles from the brand’s manufacturing facility in Ireland (26)
- 686,350 cans equivalent to 16.5 million 8 fl oz bottles of formula (Similac NeoSure and Similac Total Comfort) from Abbott’s manufacturing facility in Granada, Spain (28)
Recalled Baby Formula Sold In Canada
According to the CFIA (Canadian Food Inspection Agency), some recalled Abbott baby formulas have been accidentally sold by Shoppers Drug Mart due to an “online error.” These were the same formula products recalled in February 2022. (29)
Everyone who bought Abbott formulas from the retail pharmacy giant are told to check their products for the following codes at the bottom of the packaging or container:
- The first two digits start with 22 to 37
- The code contains any of the following: K8, SH, or Z2
- The expiration date code starts from APR 2022 or 4-1-2022 and subsequent dates
The retail pharmacy giant announced the secondary recall of these recalled infant formulas, which the CFIA points out shouldn’t have been sold to consumers at all. (29)
Newly Reopened Abbott Plant Closes Again Due To Flooding
Troubles continue to affect Abbott Nutrition as its newly reopened Sturgis plant was forced to shut again because of floods affecting Michigan. (28)
The state experienced severe thunderstorms, which resulted in power outages and floods, causing damage to some areas of the Abbott plant. (28)
The company announced that formula production will once again be delayed for a few weeks.
A comprehensive testing with an independent third party must be conducted before the FDA will allow the plant to resume operations. Once they get FDA approval, Abbott will resume EleCare production before starting with Similac and other infant formulas. (28)
Nine Formula-related Infant Deaths During FDA’s Abbott Investigation
Update: June 11, 2022
From December 1, 2021, to March 3, 2022, a total of nine formula-related baby deaths were reported while the FDA conducted its Abbott investigation. Two of these baby deaths were those included in the four confirmed Cronobacter sakazakii infections that made Similac recall its formulas in February. (30)
None of the genome sequences in the FDA investigations matched Abbott’s formula products, but all the fatalities were reportedly fed different Abbott powdered formula, including the following. (30)
- EleCare infant formula
- Similac PM 60/40
- Similac Pro-Total Comfort (Powder) infant formula
- Similac Total Comfort Easy-to-Digest Gentle Protein & Prebiotics
- Similac Advance
- Similac Pro Advance infant formula
Abbott Restarts Formula Production, Prioritizes EleCare
Update: June 6, 2022
According to Abbott Nutrition, it restarted its facility in Sturgis, Michigan, on June 4, 2022. The plant was shut down as it was the center of the massive Similac recall in February. (31)
Abbott will prioritize EleCare and other specialty or metabolic formulas made for babies with severe food allergies and digestive problems. However, these newly produced formulas aren’t likely to hit market shelves before June 20. (31)
The company clarified that it will take around three weeks for the products to reach consumers, but they’ll also restart Similac and other formula production as soon as possible.
The Sturgis plant’s reopening is believed to help alleviate the formula shortage problem and improve formula supplies in the market soon.
Foreign Companies Send Stocks As Formula Shortage Hits 70%
Update: May 31, 2022
The baby formula out-of-stock rates in the US have reached alarming levels, with retail data firm Datasembly reporting that it’s now as high as 70% across the country, as of the week ending May 22. (32)
As parents across the US scramble to find formulas, foreign companies promised to send stocks to help solve the crisis:
- From the UK, Kendal Nutricare (makers of Kendamil) said that the company will send formulas to fill around 100 trucks to the US over the next six months. (33)
- Bubs Australia will send at least 1.25 million cans to the US. (34)
The FDA assured formula makers that they will ease up some regulations to make importation easier to solve the crisis as soon as possible.
Abbott Plans To Reopen Plant Involved In Recall
Update: May 13, 2022
On May 12, 2022, the CDC (Centers for Disease Control and Prevention) announced that it had closed its investigation of the Cronobacter infections linked to Abbott Nutrition products. No additional cases have been identified as part of the investigation. (35)
However, even if the investigation is now closed, the FDA established an IMG (Incident Management Group) to continue working on the supply chain and food safety issues. (35)
Also, the recall is still in effect. It’s the investigation that’s closed.
As the out-of-stock rates soared to 43%, the FDA works with manufacturers to increase the supplies. (36)
One way of boosting the stocks is to reopen Abbott Nutrition’s Sturgis, Michigan plant, which was involved in the massive Similac recall in February 2022. (37)
In a statement, Abbott Nutrition announced that it might restart production in about two weeks, subject to FDA approval. Once production starts, the company plans to first produce EleCare, Alimentum, and metabolic formulas first, then move on to producing Similac and other formulas. (37)
However, even with the Sturgis plant’s reopening, Abbott Nutrition estimates that it could take six to eight weeks before the formula products hit the shelves.
Abbott Nutrition acknowledges their part in the baby formula shortage but said that they had improved the systems and protocols at the facility.
Some of these improvements include the following: (37)
- Reviewing and updating the training, education, and safety procedures for employees and visitors
- Updating protocols for water, cleaning, and maintenance procedures
- Upgrading the plant, such as the installation of easily cleanable, nonporous, and sanitary floors
Although it’s still unclear what impact this production resumption might have on the formula shortage, Abbott Nutrition hopes it can help improve the formula supply in the market.
White House Announces Steps To Address Formula Shortage
US President Joe Biden met with baby formula manufacturers and retailers, including Gerber, Walmart, Target, and Reckitt to discuss how to get more formula safely yet quickly onto store shelves to address the shortage. (38)
The White House also released the additional measures that the administration will follow to increase the number of formula products available without compromising your baby’s safety: (38)
Increasing Supply Through Imports
Although the US typically produces around 98% of the baby formulas it needs, the baby formula shortage due to supply chain issues and the recent recalls greatly reduced the available products. (38)
To help meet the higher demands and lower supplies, the White House plans to increase imports from key sources such as Chile, Mexico, Ireland, and the Netherlands. (38)
Cutting The Red Tape
Manufacturers typically produce different formula sizes of the same type to meet the demand, which includes around 50% coming from the WIC program (Special Supplemental Nutrition Program for Women, Infants, and Children). (38)
To simplify product offerings and increase production, the Biden administration directed the USDA (United States Department of Agriculture) to coordinate with various states to allow WIC recipients to purchase the products in stock instead of limiting them to WIC-approved options.
Cracking Down On Unfair Market Practices & Price Gouging
President Biden asked the FTC (Federal Trade Commission) to use all its available tools to identify, investigate, and monitor illegal or predatory conduct, including price gouging and unfair market practices. (38)
According to the White House fact sheet, certain people or unscrupulous retailers are using the formula shortage to buy or hoard formulas from legitimate suppliers, then marking them up for online retail to desperate parents. (38)
There were reports of formulas that normally sold for $43 to $47 being offered on eBay for as high as $800. (39)
Although retailers like Walmart, Target, and CVS have since put a cap on the quantity that customers can buy, they’re still running out of formulas. (39)
Biden Invokes Defense Production Act
As the formula crisis worsens in the US, Biden invoked the Defense Production Act for suppliers to prioritize orders from baby formula manufacturers. (40)
The first two authorizations for the Defense Production Act are “priority orders” for manufacturers Abbott Nutrition (Similac) and Reckitt Benckiser (Mead-Johnson’s Enfamil): (41)
- Abbott Nutrition’s priority orders are raw materials, including sugar and corn syrup
- Reckitt’s priority orders include filters and other single-use products to prepare oils needed in infant formula production
These priority shipments are expected to ramp up production for these two companies: (41)
- Once the Abbott plant resumes operations, they are expected to increase production by one-third.
- Reckitt plants can operate at maximum capacity with these shipments.
Biden Launches “Operation Fly Formula”
Biden launched “Operation Fly Formula” to tap military planes to import formulas from brands that meet US standards to help restock shelves. (40)
These special flights can make shipments in as fast as 72 hours, while it would normally take two weeks before products can reach the US for a regular shipment. (42)
First European Shipment Arrives In The US
The first batch of formulas (78,000 lbs) for “Operation Fly Formula” has arrived in the US. This includes specialty infant formulas from Nestle: 132 pallets of Alfamino Infant and the Alfamino Junior formulas. (41)(42)
It can provide 15% of the specialty medical-grade baby formula needed in the US, said White House National Economic Council director Brian Deese.
The products originated from Zurich, Switzerland, but were picked up by the US military plane from Germany and flown to Indianapolis. These were taken to the Nestle distribution center in the area, just about a mile away, for standard quality control checks. (41)
These specialty formulas were prioritized due to their short supply in the US and because they serve a critical medical purpose for babies with cow’s milk protein allergies.
However, these medical-grade formulas aren’t expected to hit store shelves. Instead, they’ll be sent to pharmacies, hospitals, and doctor’s offices, with priority given to the worst-hit regions. (41)
According to Agriculture Secretary Tom Vilsack, this first batch can provide formula for 9,000 babies and 18,000 toddlers for about a week. (42)
More Formula Shipments To Arrive Soon
Another flight carrying Gerber Good Start Extensive HA formula (114 pallets) from Europe is expected to arrive in the coming days. (41)
This next shipment from Germany is expected to land in Pennsylvania, again for distribution by another Nestle facility in the area. (41)
According to the White House, the first round of flights will bring a total amount of formula equivalent to around 1.5 million doses of eight-ounce bottles. (42)
States Hardest Hit By The Formula Shortage
In April 2022, the out-of-stock rates soared to 50% in the following states: (43)
- South Dakota
- North Dakota
By May, Nevada also experienced a decrease of at least 50% of its baby formula supply. (44)
House Passes $28 Million Emergency Spending & WIC Flexibility Bills
The US Congress passed two bills to help address the shortage:
- $28 million emergency spending bill
- WIC flexibility bill
$28 Million Emergency Spending Bill
The Democrats proposed a $28 million emergency spending bill to boost the FDA’s resources, including adding more staff. This was met by resistance from the Republicans, with as many as 192 voting against it. (40)(45)
Democrat Rep. Rosa DeLauro, chair of the House Appropriations Committee, said that this bill aims to increase the FDA’s staff so that more people can do the following to improve formula stocks: (40)
- Inspect international and domestic suppliers
- Acquire better data on the marketplace
- Prevent fake products from reaching store shelves.
Although it was passed, the bill received negative remarks from Republican lawmakers:
- Rep. Bill Huizenga said that more formula production is needed, not more FDA staff. (40)
- The chair of the Appropriations subcommittee that funds the FDA, Rep. Andy Harris, claimed that it wasn’t a money problem but a leadership issue. (46)
- Republican Conference Chair Elise Stefanik accused Biden of “failed leadership.” (45)
This budget measure is expected to meet resistance in the Senate as Republicans question the FDA’s seemingly lack of accountability for the shortage. Many lawmakers are also looking into possible FDA lapses that may have led to the infant deaths linked to Abbott products. (47)
Republican House representatives filed a separate bill called “Babies Need More Formula Now Act” to obtain formulas from overseas sources. (45)
WIC Flexibility Bill
Another bill lets WIC participants buy any formula product from available suppliers rather than be limited by possibly unavailable WIC-approved brands. (46)(48)
It also grants the secretary of the Department of Agriculture permanent flexibility to issue similar waivers in the event of supply disruption in the future. (46)(48)
The bill also requires formula manufacturers to create a contingency plan to protect against supply disruptions in the event of a recall. It can help prevent a similar shortage from happening again. (46)
In contrast with the budget bill, this one quickly passed in the House with a large bipartisan majority vote and was also approved by the Senate. It’s now up to Biden to sign this into law. (45)
FDA Commissioner Faces Congress
During a May 2022 investigation of the baby formula shortage in Congress, Rep. Rosa DeLauro and other lawmakers repeatedly asked FDA Commissioner Dr. Robert Califf why they took several months to investigate a whistleblower complaint on the Abbott plant’s safety violations. (49)
However, Califf said he couldn’t share details of the FDA’s ongoing investigation. (49)
He admitted that he read the complaint but didn’t specify the steps they took to immediately address the issue.
The lawmakers agreed with the FDA head that the US formula market is vulnerable to disruptions because it’s dominated by a handful of players.
As much as 90% of the US formula market belongs to: (49)
- Abbott (Similac)
- Perrigo (Parent’s Choice)
- Reckitt Benckiser (Mead-Johnson’s Enfamil)
These four companies also have federal contracts for the WIC program for low-income families, which actually accounts for 50% of US formula productions. (49)
So, it’s easy to see that major disruptions of these companies’ supplies will directly affect the formula supply in the market.
Abbott Nutrition used to top the market spot with 40% of the share and was closely followed by Enfamil. However, after the recall and Abbott’s plant closure, Reckitt Benckiser now has the top spot with an estimated 50% of the market share. (50)
To meet the higher demands, Enfamil increased production by 30%. (50)
FDA–Abbott Court Consent Decree Required Before Production Resumes
Abbott is required to comply with a court consent decree filed at the US District Court for the Western District of Michigan between the company and the FDA before production can resume: (51)(52)
- Cleaning and sanitizing the facility, including all equipment
- Restarting all the equipment to do test runs
- Conducting multiple tests
- Checking on all ingredients
- Hiring a third-party expert who will independently review its processes
The company also needs to review and change the following: (51)
- Environmental monitoring program
- Product sampling and testing plans
- Employee training programs
To prevent a repeat of the previous issues that led to the recall and formula shortage, the court consent decree also requires Abbott to immediately stop production and notify the FDA if any contamination is detected. (52)
Abbott To Take “Serious Steps” To Address Formula Shortage
Abbott CEO Robert Ford detailed the “serious steps” the company is taking to help address the formula shortage. He also apologized for the company’s role in the crisis. (53)
With Abbott having as much as 40% share of the formula market, the Sturgis plant shut down after the recall worsened the shortage, which began in 2021. (54)
To help address the infant formula shortage, Ford said that Abbott is taking these “serious steps”: (53)
- Converting adult nutrition product production lines to focus on ready-to-feed liquid infant formula production at an Abbott facility in Columbus, Ohio
- Acceleration of production processes
- “Rigorous inspections” of products
- A $5 million fund for families with babies hospitalized for not having access to specialized formula products
- Air-shipping millions of the company’s most widely used powdered baby formulas from an FDA-approved facility in Ireland
Ford also assured consumers that they will do the following once production resumed: (53)
- More than double the production
- Invest in upgrading safety
- Improve quality processes and equipment
- Make significant investments so the formula crisis doesn’t happen again
Ford added that they issued the voluntary formula recall because they didn’t want to risk the babies’ lives or health.
He clarified that none of the bacterial strains sequenced from the reported infections were found in Abbott’s retained products. (53)
FDA Refutes Abbott’s Claim On The Different Bacterial Strains
According to Abbott, bacterial strains from the sick babies didn’t match those taken from Abbott’s plant in Sturgis, Michigan, based on the FDA investigation. (40)
However, FDA officials recently refuted Abbott’s claim. (40)
Food director Susan Mayne explained that they weren’t able to determine the link between Abbott products and the babies’ cases because they only got sequences from two babies. (40)
They weren’t able to get samples from the other babies.
Abbott’s Buyback Program & High Profits While Plant Needed Repairs
Groups like Groundwork Collaborative, a progressive economic advocacy group, slam Abbott for enjoying record profits as high as 94% between 2019 and 2021, during the same period when bacteria were detected in its products. (55)
Abbott’s net profits increased from $3.6 billion to $7.1 billion two years before the recall, according to Securities and Exchange Commission records. (55)
The company also increased dividends by over 25%, offering shareholders a stock buyback program that was worth $5 billion. (55)
Rakeen Mabud, Groundwork Collaborative’s chief economist, said that instead of improving its facility and making productive investments, the company chose to enrich shareholders. (55)
American Economic Liberties Project senior fellow Moe Tkacik pointed out that buybacks were illegal until 1982 and were considered a form of manipulation. (55)
Tkacik also believes that restrictions should be imposed on companies like Abbott that either receives federal funding or whose largest customers are federally funded programs such as the WIC. (55)
However, Abbott claims that its product’s safety was not hurt by the buyback program. Even with the stock buyback, the company said it was still able to improve facilities with its “strong balance sheet.” (55)
Senate Investigation On Abbott’s Buyback Program
The Senate Finance Committee plans to investigate Abbott’s stock buyback program and check the investments towards plant safety improvements as they enjoyed record revenues. (47)(55)
Possible Criminal Charges Over Baby Formula Shortage
Who’s to blame for the baby formula crisis?
House Speaker Nancy Pelosi believes that there might be a need for an indictment to avoid a similar crisis from happening in the future. However, she wants that done after the nationwide infant formula shortage is resolved. (56)
Although she didn’t specify the details of the possible criminal charges, Pelosi clarified that they aren’t associated with any of her colleagues. (56)
Some Babies Hospitalized Due To The Formula Shortage
Some babies, many of whom needed specialty formulas like Elecare because they couldn’t digest full proteins, were hospitalized in several parts of the US amid the formula shortage.
The kids relied on the building blocks of proteins called amino acids in EleCare as nourishment because these smaller protein components didn’t have to be digested.
Because EleCare was included in the February 2022 Abbott recall, these kids had to try other formulas. Most of them couldn’t tolerate the new options, leading to dehydration and malnutrition. (57)
For kids with these medical conditions, finding the right formula can be a difficult process. The new one shouldn’t trigger potentially dangerous reactions (e.g., dehydration or diarrhea) but has to meet their nutritional needs.
There were also babies who didn’t have medical issues but were hospitalized due to intolerance to the new formula they were taking. Others experienced mineral imbalances after taking homemade formula.
Data from different hospitals across the US showed several children hospitalized due to the formula shortage:
- Tennessee – Two children were hospitalized at Le Bonheur Children’s Hospital in Memphis, Tennessee, due to EleCare shortage (both couldn’t absorb full-size proteins). (57)
- South Carolina – Three babies were admitted to the Medical University of South Carolina Shawn Jenkins Children’s Hospital in Charleston for intolerance, while one was hospitalized for mineral imbalance after taking homemade formula. (42)
- Georgia – An undisclosed number of babies and some older kids were admitted to Children’s Healthcare of Atlanta in Georgia for malnutrition. They had specific dietary needs and weren’t able to tolerate new formulas. (58)(59)
- Wisconsin – Several children (the exact number also undisclosed) were treated at Children’s Wisconsin for malnutrition after taking inappropriate substitutions or homemade formula. (59)
Children’s Wisconsin warns parents that homemade formulas can cause liver and/or kidney damage. These might also cause a baby’s heart to stop because of an imbalance. (59)
Watered-down formulas can also lead to brain swelling or organ failure. (59)
Safe Formula Preparation And Storage
The CDC recommends carefully reading the instructions on the formula’s container. Different formulas may have different requirements or instructions for: (60)
- How many scoops you’ll need to prepare with a certain amount of water
- Storage instructions
When preparing and storing your baby’s formula, you should also follow these safety precautions: (60)
- Always wash your hands with soap and water before preparing the bottles and feeding your baby.
- Prepare your baby’s formula on a clean, sanitized surface.
- Keep bottles clean and sterilized. It would be better to keep these items away from high-traffic areas in your home.
- Always use water from a safe source in preparing any formula. Contact your local health department if you’re unsure about the safety of your tap water.
- Only use the correct amount of water listed on the formula’s instructions. Too little water may cause your baby to be dehydrated or could cause strain on their digestive system and kidneys. But too much water may lead to a formula that doesn’t meet your baby’s nutritional needs.
- Always keep the formula container tightly closed and stored in a cool, dry place indoors.
- Most formulas need to be consumed within one month after opening.
- Always check for discoloration, weird smells, or signs of contamination before preparing a bottle.
- Always check the expiration date (“use by” date). Never use an expired formula.
- Use a prepared formula within two hours of preparation or one hour after feeding begins.
- You can store premixed bottles in the fridge for 24 hours, but only if your baby hasn’t started feeding on them.
- Any used or leftover formula should be discarded after each feed, even if there’s still plenty of liquid inside the bottle. The combination of your baby’s saliva and formula may cause bacteria to grow in these leftovers.
- You should never give your baby formula from a recalled lot or batch with contamination or other safety issues.
What To Do If Your Baby’s Formula Or Food Has Been Recalled
After any formula recall or food recall announcement, do the following:
- Double-check the product name, batch number or lot code, and the “use by” or expiration date.
- If the product you have is part of the recall, immediately stop giving it to your baby and contact the manufacturer or store for the refund or replacement process.
- Call your pediatrician if your baby shows signs of stomach upset or other medical issues from drinking the recalled product.
Formulas Or Products That Haven’t Been Recalled
The following formulas haven’t been recalled:
- Similac Pro-Advance Non-GMO Infant Formula with Iron
- Earth’s Best Non-GMO Soy-Based Infant Powder Formula
- Kabrita Goat Milk Toddler Formula Powder
- Else Plant-Based Complete Nutrition for Toddlers
- Enfamil Neuropro
- Enfamil A2 with Prebiotics
- Happy Baby Organics Infant Formula
- Enfamil Enspire Baby Formula with Iron
- Meyenberg Whole Powdered Goat Milk, Gluten Free
But make sure to always check with your pediatrician before starting or switching formulas.
Baby Formula Recalls From Other Brands & Products
Baby Formula Recall 2022
ByHeart Formula Recall
Update: December 12, 2022
ByHeart baby nutrition company voluntarily recalled five batches of their Whole Nutrition Infant Formula on December 11, 2022, due to the possibility of cross-contamination with Cronobacter sakazakii. Infections with this bacteria are rare but can be deadly to infants.
Recall Of Similac Ready-to-Feed Liquid Products
Update: October 16, 2022
In mid-October 2022, Abbott Nutrition voluntarily recalled some lots of the following ready-to-feed liquid products (2 fl oz or 59 ml bottles) because of improperly sealed caps that can cause possible spoilage: (61)
- Similac Stage 1
- Similac NeoSure
- Similac 360 Total Care
- Similac 360 Total Care Sensitive
- Similac Special Care 24
- Similac Pro-Total Comfort
- Similac Water (Sterilized)
- Pedialyte Electrolyte Solution
Only these products and lots are included in this recall. (Read our Similac recall article for the list of bottle and case/carton lot numbers) (61)
According to Abbott’s recall advisory, babies can experience vomiting, diarrhea, or gastrointestinal symptoms if they are fed with these spoiled products. (61)
Don’t feed any of these recalled products to your baby.
Contact Abbott Nutrition for more information through this number:
- US: 1-800-986-8540
Update: March 29, 2022
- On February 17, 2022, Abbott Nutrition recalled Similac, Alimentum, and EleCare powdered infant formulas due to possible contamination with bacteria strains, specifically Cronobacter sakazakii and Salmonella. One baby reportedly died from Cronobacter infection after allegedly drinking Similac formula. Affected lots are those with codes that contain K8, SH, or Z2, with the first two digits of the codes starting from 22 to 37. (62)
- On February 28, 2022, the company announced an additional recall: Similac PM 60/40 with lot # 27032K80 (can) or lot # 27032K800 (case) following the death of a second infant linked to this formula. (61)
- The FDA reportedly found several safety issues during their plant inspection, including a lack of temperature controls, unsanitary conditions, and workers failing to follow safety protocols correctly. (62)
- This massive recall worsened the formula shortage in the US.
Angel Formula Recall
On January 7, 2022, the FDA recalled “Healthy Beauty” Angel Formula by Moor Herbs for failure to meet the safety requirements for infant formulas: (63)
- No pre-market notifications to the FDA
- May contain iron, potassium, and sodium concentrations that are much higher than the maximum limits (the FDA recall advisory didn’t indicate their test values)
- The product fails the FDA’s labeling requirements because it doesn’t have a UPC (Universal Product Code) or a manufacturing lot code.
What Baby Formula Is On Recall 2021?
The following are some of the recalls from other formula brands:
Able Groupe Baby Formula Recall
- Able Groupe recalled all lot codes of HiPP, Holle, Kendamil, and Bioland (Lebenswert) formulas in August 2021 for failure to meet FDA requirements for pre-market notifications, minimum iron levels, and proper labeling (for possible iron supplements). (64)
- These are European formulas imported by LittleBundle. (64)
- According to the recall advisory, regularly feeding your baby with formula with low iron levels (below the minimum of 1 mg iron per 100 calories) may lead to iron deficiency anemia. This condition can lead to irreversible cognitive or functional development outcomes. (64)
- For return or refund processing, customers were instructed to contact [emailprotected].
Designed by Nature Recall
- The FDA recalled all the baby formula products (base formula, goat, and cow milk) of Designed by Nature on June 14, 2021, for possible health risks due to incorrect labels. They are not intended for use as infant formula, but that’s not indicated on the labels. (65)
- The company also admits not testing for the presence of Cronobacter, which can be dangerous, even deadly, for babies. (65)
Other formulas recalled in previous years:
Kirkland Signature Brand, Non-GMO Formula For Babies Sensitive To Lactose Recall (Canada)
- Costco Wholesale Canada Ltd. recalled the formula on October 25, 2019, for possible Cronobacter spp. contamination in products distributed at Costco stores in Canada. (66)
- The recall affected lot codes EXP 2020 NO 05 T05DVBV (1.36 kg) and EXP 2020 NO 05 T05DVBV (2-pack, 2 x 1.36 kg). (66)
Calcilo XD Formula Recall
- On September 17, 2019, Abbott Laboratories recalled Calcilo XD powder cans (13.2oz / 375g) with lot number 79696K80 over inconsistencies in the aroma and color of this specific batch. (67)
Similac TummiCare One Infant Formula Recall (Philippines)
- Abbott Laboratories recalled this formula in the Philippines on August 14, 2019, due to differences in the preparation scoop size and the label instructions. It only affected batch no. 03518QU. (68)
- The product itself is safe to consume. But incorrect formula preparation using the scoop (included in the box) might not provide enough nutrients to support normal growth. (68)
Parent’s Choice Advantage Infant Formula Recall
- Perrigo Company plc recalled Parent’s Choice Advantage Infant Formula on June 21, 2019, for possible metal foreign matter. It only affected one batch with lot code C26EVFV and “use by” date of February 26, 2021 (35-ounce, 992-gram containers). (69)
- You can Consumer Affairs if your formula is included in this recall. (69)
Store Recall of Milupa Aptamil 1 Pronutra (Slovenia)
- Retailer Mueller Drogerija recalled this Danone formula in August 2018 after a customer in Slovenia found some dead insects in a pack of this formula. (70)
- The recall affected the 800-gram package with item number 100762029 and date 13-10-2019. (70)
Dumex Mamil Gold Infant Milk Formula (Step 1) Recall in Singapore
- Dumex recalled this formula (850g) with batch number 09117R1 and expiry date 11-9-2019 over possible contamination with Cronobacter sakazakii. (71)
Bebe Mandorle Stage 2 (Bio) Recall
- La Mandorle recalled this product on November 5, 2018, for possible contamination with the deadly bacteria Cronobacter sakazakii. (72)
Lactalis Nutrition Santé (LNS) Recall
- Lactalis Nutrition Santé (LNS) recalled formulas from name brands Picot AR, Celia, Milumel, and Taranis on December 2, 2017, for possible contamination with Salmonella agona. (73)
- The formulas were manufactured in Craon, France, starting on February 15, 2017. The contaminated formulas can cause gastrointestinal problems, vomiting, diarrhea, headaches, chills, fever, and abdominal cramps. (73)
Gerber Good Start Soy Formula (Tampering)
- In May 2017, a two-month-old toddler was rushed to the hospital in Arizona after consuming a Gerber Good Start Soy formula that may have been tampered with. (74)
- Police arrested Jennifer LaPlante concerning the incident. She reportedly replaced the formula contents with baking flour, sugar, or rice cereal before returning them to the store for a refund. (74)
- Geber didn’t issue a recall because this was considered an isolated incident. (74)
Sammy’s Milk Baby Food (Powdered Infant Formula) Recall
- In September 2016, the FDA recalled this Graceleigh, Inc. formula for failing to meet infant formula regulations. The product has low iron content and isn’t tested for the deadly Cronobacter pathogen. (75)
Why Was Similac Recalled?
- Abbott Laboratories Inc. recalled several Similac formulas in 2010 due to possible contamination with larvae or full-grown adults of the small common beetle discovered in one area of a plant in Sturgis, Michigan. (76)
- This recall affected as many as 5 million Similac infant formula containers. (77)