Over the past several years, there have been numerous cases of toxins and bacteria found in infant formula in the U.S., leading to product recalls, and in some cases, nationwide recalls.
Between 2021 and 2022, four infants were sickened by a different germ after consuming formula made by Abbott Nutrition. Two of the babies died. No direct link was found between the Abbott products and the infections caused by a different germ, cronobacter sakazakii, but FDA officials closed the company’s Michigan plant after contamination and other problems were detected. Abbott then recalled top brands of infant formula, triggering a nationwide shortage that lasted months. This recall is now referred to as the most consequential formula recall in modern U.S. history.
In 2023, Reckitt Benckiser/Enfamil issued a recall of their own. About 145,000 cans of powdered, plant-based formula were recalled for potential Cronobacter contamination.
Then, in 2024, Nutramigen issued a recall for the possible Cronobacter contamination of over 600,000 cans of powdered infant formula.
In 2025, ByHeart issued a recall due to concerns of bacteria causing infant botulism. The U.S. Food and Drug Administration is investigating 84 cases of infant botulism detected since August 2025. This contamination event raises questions about spore-forming bacteria controls in powdered infant formula and the manufacturing plants producing those cans of formula.
Most recently, on May 4, 2026, the a2 Milk Company is recalling more than 16,000 units of its a2 Platinum Premium USA infant formula tins due to cereulide being found in them, according to a notice issued May 2 by the Food & Drug Administration. The presence of this toxin can cause nausea and vomiting. This most recent contamination event is relevant because it involves toxin contamination, not bacterial contamination, and shows emerging hazards beyond just the Cronobacter bacteria.
Across all of these U.S.-based recalls, the pattern is clear – powdered infant formula is not sterile, which remains a structural safety issue. Similarly, many of these aforementioned recalls stem from environmental contamination in manufacturing plants, raising questions about the monitoring and enforcement of standards in those settings.
What is being done to address these contamination events on a global scale?
There are many different organizations and agencies that are tackling the issue of contaminated powdered infant formula from different angles.
The International Baby Food Action Network (IBFAN)(1) continues to advocate for adoption of the WHO Code and its subsequent World Health Assembly Resolutions and encourages countries across the globe to strengthen their monitoring and enforcement of the WHO Code. In response to calls from IBFAN and other health advocacy organizations about the recent crises, the WHO and the Food and Agriculture Organisation (FAO) have begun the process to update their risk assessments and scientific advice (Microbiological Risk Assessment), which is now nearly 20 years old, and no longer adequate to prevent contamination with spore-forming pathogens and bacterial toxins.
IBFAN continues to push for a new World Health Assembly resolution to protect families from these ongoing contamination events. A new resolution would:
- Ensure health facilities follow Baby Friendly recommendations, [2] and provide mandatory paid maternity protection and leave.
- Speed up the updating of the 20 year-old Codex and WHO Guidelines that do not address Bacillus cereus, Clostridium botulinum or heat-resistant spore forming contaminants;[1]
- Ensure that national food safety surveillance and verification is independent, transparent and free from commercial interference and that whistle-blowers are listened to;
- Ensure parents are better informed through clear labelling and family support in line with WHO marketing recommendations and on the regulation of digital marketing;
- Ensure health facilities follow Baby Friendly recommendations, [2] and provide mandatory paid maternity protection and leave.
What is being done to address these contamination events in the U.S.A?
Congresswoman Rosa DeLauro introduced the Infant Formula Safety Modernization Act in March, 2026. According to the office of the bill sponsor, the bill would:
• Expand required pathogen testing. Direct FDA to develop a comprehensive list of pathogens and microorganisms that infant formula manufacturers must test for — moving beyond the current requirement, which covers only Cronobacter and Salmonella. Clostridium botulinum would be required on that list.
• Mandate environmental testing. Require standardized environmental monitoring inside infant formula facilities — a proactive practice that detects contamination in the production environment before it reaches the product. This testing is not currently required by law, despite its importance.
• Set consistent testing standards. Specify the frequency of environmental testing so that all manufacturers operate under uniform FDA-set standards, rather than each company setting its own.
• Require early FDA notification. Compel manufacturers to notify FDA of any positive pathogen test — even if the affected formula has not left the facility. Under current law, companies are not required to alert FDA unless adulterated formula has already entered the supply chain.
• Hold foreign manufacturers to the same standards. Ensure that all infant formula sold in the United States — whether produced domestically or abroad — meets the same safety requirements.
• Strengthen Congressional oversight. Require the Secretary to notify Congress of any confirmed positive pathogen test in finished infant formula, as well as any “Official Action Indicated” finding during an FDA facility inspection — the agency’s most serious compliance designation, requiring corrective on.
It is unclear what safeguards can be in place to prevent Conflicts of Interest from influencing the testing of infant formula products and manufacturing plants. It is also unclear, and outside of the scope of this Act, what can be done to notify the public about contamination events in the U.S., as an independent, public notification system currently does not exist.
INFACT USA and INFACT Canada both met with the sponsor’s office and recommended that the bill be amended to require:
- Any outsourced testing laboratories or other facilities contracted must be free of improper or undue influence or conflict of interest.
- Labelling must contain warnings that the products are not sterile and full information on the recommended reconstitution, storage, handling and use by competent authorities.
- Mandate rapid public notification and maintain a centralized data reporting base when infants are hospitalized with suspected foodborne, bacterial or viral illness linked to the feeding of baby food and infant formula products.
Lack of congruency between contamination events and FDA reporting
Ironically, just one week before the most recent announcement from a2 and their recall, the FDA released results from an examination focused on chemical contaminants in infant formula available on the U.S. market. The FDA is concluding from that examination that infant formula is “safe.” (2)
The FDA tested 312 samples from 16 brands, but did not say in its report what brands it tested. Additionally, despite claiming a rigorous methodology, the testing program did not include foodborne pathogens such as Cronobacter, Listeria, Salmonella and E. coli.
The United States doesn’t have a legal limit for any of the metals in infant formula the FDA tested for. Consequently, when the FDA calls formula “safe,” there is no standard behind that word (3). A summary of the results can be found below, as reported by Food Safety News.
- Mercury was not detected in 296 out of 312 samples (95 percent). Among all samples, concentrations ranged from not detected to 0.3 ppb. Given the high number of non-detects, a 95th percentile and median were not calculated.
- Cadmium was not detected in 106 out of 312 samples (34 percent). Among all samples, concentrations ranged from not detected to 1.5 ppb. 95 percent of all samples had less than 1.1 ppb of cadmium. The median cadmium concentration was 0.2 ppb.
- Lead was not detected in 61 out of 312 samples (20%). Among all samples, concentrations ranged from not detected to 1.1 ppb, with 95% of samples containing less than 0.5 ppb of lead. The median lead concentration was 0.2 ppb.
- Arsenic was not detected in 18 out of 312 samples (6 percent). Among all samples, concentrations ranged from not detected to 4.7 ppb. 95 percent of all samples had less than 2.0 ppb of arsenic. The median arsenic concentration was 0.5 ppb.
- Pesticides: Each of the samples were tested for 318 different pesticides, including glyphosate and glufosinate. 309 samples (99 percent) had no detectable pesticides, and glyphosate and glufosinate were not detected in any samples. Given the high number of non-detects, a 95th percentile and median were not calculated. Only three samples had detectable pesticide levels, all at very low concentrations: 0.25 ppb chlorpyrifos in one sample, 0.20 ppb malathion in another sample, and 0.20 ppb piperonyl butoxide in a third sample.
- PFAS: Each of the samples were tested for 30 different PFAS compounds. Most PFAS compounds (25 of 30) were not found in any samples. Five PFAS were detected in a subset of samples at concentrations ranging from 0.51 ppt to 150 ppt, depending on the compound. The most commonly detected was Perfluorooctanesulfonic acid (PFOS), found in half of samples at detectable concentrations ranging from 0.51 to 6.0 ppt, with 95 percent of all samples containing less than 2.9 ppt of PFOS. Given the high number of non-detects, the median was not calculated. PFAS levels are often reported in parts per trillion (ppt) because testing methods can detect these contaminants at extremely low concentrations. One part per trillion is equivalent to one second in 32,000 years, or one drop in 1,000 Olympic-size swimming pools.
- Phthalates: Each of the samples were tested for 21 phthalates and 1 non-phthalate plasticizer. Phthalates were not detected in 167 out of 312 samples (54 percent). Among the compounds tested. Seven phthalates were not detected in any samples. Five phthalates were rarely detected (in fewer than 2 percent of samples). The remaining compounds that were detected had concentrations ranging from not detected to 145 ppb.The most commonly detected phthalate compounds were DEHP and DINP:
- DEHP was not detected in 253 out of 312 samples (81 percent). Among the samples, DEHP concentrations ranged from not detected to 57 ppb. Given the high number of non-detects, a 95th percentile and median were not calculated. DINP was not detected in 260 out 312 samples (83 percent). Among the samples, DINP concentrations ranged from not detected to 145 ppb. Given the high number of non-detects, a 95th percentile and median were not calculated.
- Human milk: While this phase of testing focused specifically on infant formula products, the FDA also tested a limited number (110) of human milk samples from a single state donor human milk bank for arsenic, cadmium, mercury, and lead. Overall, the majority of samples (85 percent) had at least one detectable contaminant, while 17 samples (15 percent) had no detects of any of the contaminants. Mercury demonstrated the highest detection rate at 61 percent, followed by cadmium at 57 percent, arsenic at 33 percent, and lead at 30 percent.
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