Several baby formula recalls since early 2022 involving brands like Similac, Enfamil and Gerber have sparked concerns about contamination and safety. The recalls led to shortages and new regulatory and industry changes to prevent future problems.
Since early 2022, there have been several baby formula recalls following reports of contaminated baby formula. The recalls involved different manufacturers.
On February 17, 2022, Abbott launched a preemptive and voluntary recall of powder formulas from its various brands. The recall occurred after four consumer complaints linked the formula to the harmful bacteria Cronobacter sakazakii and Salmonella Newport. This contributed to a significant national baby formula shortage.
On December 11, 2022, baby formula company ByHeart voluntarily recalled five batches of its products. This was because a sample from a third-party facility used for the canning step in production tested positive for Cronobacter sakazakii. However, none of ByHeart’s products tested positive for bacteria, and the company didn’t receive complaints.
In 2023, Reckitt recalled 150,000 cans of plant-based infant formula, and Perrigo recalled several lots of Gerber Good Start powdered formula. These recalls were both due to potential Cronobacter sakazakii contamination.
These recalls do not relate to necrotizing enterocolitis, a severe gastrointestinal condition primarily affecting premature infants. There have been reports of premature babies who were fed cow’s milk-based baby formula and then developed necrotizing enterocolitis.
However, the baby formula recalls only pertain to potential bacteria contamination. There have been no formula recalls regarding the product’s alleged connection to necrotizing enterocolitis.
Despite this, parents have filed lawsuits against baby formula manufacturers, claiming the companies didn’t warn parents and medical providers about the risk of necrotizing enterocolitis. These include lawsuits against Abbott Laboratories and Mead Johnson.
The U.S. Food and Drug Administration (FDA), responsible for ensuring food safety, is now inspecting and testing more factories, both in the U.S. and abroad, that make baby formula. It has also updated the inspection guidelines, focusing more on testing the environment where the formula is manufactured and looking closely at the supply chain.
In August 2023, the FDA sent warning letters to three companies that make infant formula, asking them to follow safety rules more carefully. Then, in October 2023, the FDA updated its regulations for infant formula to strengthen safety checks further.
Critical food safety updates, particularly for infant formula companies, require formula manufacturers to inform the FDA if they stop or have production problems that could cause shortages. Additionally, new steps are in place to keep Congress updated during infant formula recalls.
In response to recent shortages caused by contamination issues and recalls, Abbott has restarted its Similac formula production at its Sturgis, Michigan facility. Other companies, like Enfamil producer Reckitt Benckiser, have also increased their production to help meet the growing demand for infant formula.
To further help with shortages, the FDA is allowing infant formula to be imported from other countries, using enforcement discretion to allow twelve new companies to bring products to the U.S. market.
Some of Abbot’s most popular baby formula brands have been recalled, including Similac, EleCare and Alimentum. ByHeart formula was also recalled. These recalls include multiple formulas within each product line.
These recalls relate to contamination at production facilities where Cronobacter sakazakii or Salmonella Newport were detected.
The largest Abbott brands involved in the February 17, 2022 recall included Similac and Alimentum, manufactured in Abbott’s facilities in Sturgis, Michigan. The recall only affected specific lots of the products.
The CDC advises you to review the codes on the bottom of your formula package to see if it’s part of the recall. You can also check the manufacturer’s website online to confirm recalled products. Abbott offers a product lookup on its site to help consumers.
Recalled Abbott formulas:
Abbott has a hotline for more information about the recall. The number is 1-800-986-8540.
Enfamil formulas were not part of any recall. All Enfamil, Nutramigen and PurAmino-branded products continue to be safe to use. Reckitt-Mead Johnson manufactures Enfamil products.
Other Mead Johnson products are named in some necrotizing enterocolitis lawsuits. Speak with your child’s pediatrician if you have questions or concerns about the safety of any formula product.
In February 2023, Reckitt voluntarily recalled two batches of Enfamil ProSobee 12.9 oz Simply Plant-Based Infant Formula due to potential cross-contamination with Cronobacter sakazakii, a bacteria that can cause serious infections in infants. The recalled lots totaled nearly 150,000 cans.
The affected formula had UPC Code 300871214415.
In December 2023, Reckitt issued another recall, this time for Enfamil Nutramigen Powder in 12.6 and 19.8 oz cans.
The affected formula containers had UPC Codes 300871239418 or 300871239456.
On March 17, 2023, Perrigo Company PLC issued a recall for Gerber Good Start SootheProTM Powdered Infant Formula due to potential Cronobacter contamination.
Later, Associated Wholesale Grocer also recalled the affected Gerber Good Start SootheProTM sold at its retailers.
The FDA recommends looking at the lot code, a multi-digit number on the formula container, to determine if your powdered infant formula was recalled.
In addition to the products listed above, Abbott has recalled Similac PM 60/40 with lot codes 27032K80 (can) and 27032K800 (case).
If your baby’s formula was recalled, speak with your child’s pediatrician. They may have sourcing information and can recommend the best substitutions for your baby’s needs.
Don’t buy imported formula online because the FDA does not approve it. Parents should also avoid making their own formula or diluting the formula they have with water since this can lead to serious health hazards. You should not use toddler formula if your baby is under one year of age.
If your baby is 12 to 15 months old, talk to your pediatrician about transitioning them to milk or a dairy alternative with sufficient calcium. Discussing your child’s specific food intolerance and nutritional needs with their pediatrician can be helpful.
Editor Lindsay Donaldson contributed to this article.
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