We, all of us, need to rethink how we produce infant formula in the U.S. – Botulism should not be an option

The FDA has released documents showing that unsanitary conditions at a production plant for ByHeart infant formula and positive tests for pathogens have been going on since at least 2022.

The company is currently under investigation because of an outbreak of infant botulism traced to its powdered infant formula. 

As of Nov. 26, there are 37 confirmed cases of infant botulism among babies who were fed ByHeart formula. All of the babies have been hospitalized. Also, there are more than 70 cases that are pending tests to determine whether they have been infected with the strain of botulism found in ByHeart formula.

The company says it has found botulism in unopened containers of its formula and has recalled all of its products. The Food and Drug Administration has found that stores are continuing to sell the recalled products. The agency is urging parents and caregivers to not use the ByHeart formula.

Food Safety News filed a Freedom on Information Act request with the FDA earlier this month for all records related to ByHeart, but has not received any documents as of Nov. 26.

Inspection reports from 2023 and 2024, made public on Nov. 26 by the FDA, detail problems discovered at the ByHeart production plant in Allerton, IA, including positive tests for Cronobacter and leaking roofs and cracks in equipment.

The FDA has also released a warning letter sent on Aug. 30, 2023, that covered an inspection from Dec. 21, 2022, through Feb. 17, 2023. Both inspection reports cover problems discovered during the 2022 inspection and subsequent inspections.

In its 2025 report — which is heavily redacted — on an unannounced inspection in February this year the FDA cited a variety of problems including rodent activity and ByHeart’s failure to properly monitor floor conditions. 

The FDA had seven discussions with ByHeart management covering significant pest activity, quality assurance employees missing reviews, failure to secure doors, failure to collect swabs during production for pathogen testing, and failure to take measures to prevent water leaks.

The FDA investigators found that the company approved and released an ingredient that was not manufactured, packaged, labeled or held under conditions to prevent adulteration (contamination).

The investigators also found that ByHeart did not exclude pests from its food plant and did not maintain its building in a manner which guarantees production and packaging of infant formula in a clean and sanitary environment. The inspection report also states that ByHeart’s plant was not designed to facilitate maintenance and sanitary operations.

In the investigation report, the FDA inspector noted that a ByHeart representative from the company’s headquarters stated that the company received almost 2,000 complaints related to products produced by the base powder. Complaints are sorted into three categories: Health; Quality; Sensitive/Serious. 

Health is related to gastro illnesses. Quality is related to tastes, smells, appearance, damages, and foreign materials. Sensitive is related to Salmonella/pathogen illnesses. The firm stated there were reportedly 1,915 quality complaints, 930 health related complaints, and 9 sensitive complaints.

The FDA inspection report noted that ByHeart has made several improvements at its Allerton, IA, plant, including ceiling repairs, floor seals and exhaust equipment repairs.

A ByHeart official told FDA investigators that there haven’t been any changes to processes or equipment on its infant formula manufacturing line since 2022. Inspection reports from 2023 and 2024 document ongoing problems dating back to 2022.

ByHeart uses a third-party company to conduct inspections of equipment. The last inspection was Oct. 31, 2024.

The company reports test swabbing for Cronobacter and Salmonella and other pathogens, but not for botulism. It has found Cronobacter in its facility.

An FDA inspector observed employees handling ingredients in such a way as to allow for contamination.

According to the inspection report from January 2024, a verbal warning was given to the firm and corporate management, emphasizing the need for compliance with the Food, Drug and Cosmetic Act. During this interaction, consequences for non-compliance were clearly communicated to underscore the importance of adhering to the Act.

“I (the inspector) reviewed the firm’s complaint file from June 2023 to the present. There were numerous complaints regarding product quality and some specifically mentioning issues like spitting-up and diarrhea. Complaints related to these health concerns are investigated by corporate headquarters. The ages of the infants involved in these complaints were 71 days and 90 days. There were no reports of serious injuries or illnesses. Additionally, there were complaints related color and flavor,” according to the 2024 inspection report. 

During the January 2023 inspection, dozens of cracks in equipment, floors and the roof were found. Such cracks can harbor foodborne pathogens, including Clostridium botulinum, which causes botulism poisoning.

The 2024 inspection report details problems, including:

• Records lack specific details regarding the timing of cleaning, sanitizing and the aggregate production number of each infant formula processed between equipment startup and shut down for maintenance;
• The firm’s electronic system is from 2009 and has not been validated since then;
• Gaps in some records and lack of documented records;
• Cronobacter was found in production and storage areas;
• The firm did not provide FDA with a copy of an audit.

“I (the inspector) provided a verbal warning to all present individuals, emphasizing the importance of compliance with the FD&C Act and highlighting the consequences for non-compliance”

The 2023 inspection was merely of records and did not include sampling of the plant or products. It was heavily redacted with numerous paragraphs blacked out. The inspection was conducted June 27 and 28, 2023, and released Nov. 26 this year. The previous inspection was conducted by FDA on May 15, 2022. It found numerous problems.

Many of the problems cited in the 2023 report were repeated in the 2024 report.

The following observations were documented in the 2023 report and covered problems from the 2022 inspection. Those observations included:

• Not having a written sanitation preventive control, monitoring, corrective action and verification procedures appropriate to significantly minimize or prevent the hazard requiring a preventive control;
• Not having a person who conducted an audit relating to infant formula quality control procedures was directly responsible for matters that the person was auditing;
• Measuring devices were not calibrated, which were used to verify that ingredient weights for infant formula bases were accurate;
• Not maintaining a building used in the manufacture, processing, packing or holding of infant formula in a clean and sanitary condition. 

“The current inspection focused on the firm’s corrective actions to the previous inspection. The firm’s food safety plan and hazard analysis were reviewed; the plan was not updated with the current ownership. Local firm management stated the firm’s processes and procedures are currently under review by ByHeart corporate leaders and will be updated before Blendhouse Allerton manufactures PIF (powdered infant formula,” according to the 2023 inspection report.

“All individuals present (during the inspection) were provided a verbal warning to comply with the FD&C Act and the consequences for non-compliance.

“I informed all parties that continuous improvement and routine maintenance to this aging facility would be vital to prevent contamination of the powdered infant formula supply. Hillary Sibert, senior VP for quality, affirmed the company’s commitment to (b) (4) manufacturing quality food products. She stated the facility is currently beginning trials with the intention of sending product to market this year.”

The August 2023 warning letter, which was partially redacted, included references to activities dating back to September 2022. During the inspection that led to the warning letter, FDA investigators found significant violations of Title 21, Code of Federal Regulations, Part 106 (21 C.F.R. Part 106), Infant Formula Requirements Pertaining to Current Good Manufacturing Practice, Quality Control Procedures, Quality Factors, Records and Reports, and Notifications (the Infant Formula Rule). 

The warning letter documented bacteria, a leaking roof and unsanitary conditions at the production plant.

“On Oct. 17, 2022, you (ByHeart) notified (redacted) that a batch of ByHeart Whole Nutrition Infant Formula finished product had tested positive for Cronobacter spp. and was later confirmed as Cronobacter sakazakii (“C. sakazakii”). The infant formula base, which was a component of the contaminated finished product, was manufactured during a continuous production campaign at the (redacted) facility from July 13, 2022, through Aug. 23, 2022. The infant formula base from this campaign was then blended and packaged as a finished product at one of your third-party contract manufacturer’s facilities from Sept. 15, 2022 through Oct. 7, 2022,” according to the warning letter.

The letter noted that ByHeart initially said the positive test was due to a laboratory error, but that was later disproven.

The FDA’s review of ByHeart’s records showed that the company did not work with its third-party contract manufacturer to further investigate the origin or root cause of the finished product testing positive for the pathogen. As the parent company and entity making all product disposition decisions, the FDA told ByHeart officials it is their responsibility to investigate all aspects of the production process for your products, including operations conducted at your (redacted)facility and your third-party contract manufacturer’s facility, when evaluating the potential root cause for a product contamination event.

In response to the positive test for Cronobacter, ByHeart initially only held and destroyed one lot of infant formula. ByHart directed the release of all other formula. Following discussions with FDA, ByHeart conducted a voluntary recall of the remaining five lots of formula from the same Sept. 15, 2022 – Oct. 7, 2022, campaign that it had previously released into U.S. commerce.

Republished with permission from Bill Marler and Marler Clark. Copyright (c) Marler Clark LLP, PS. All rights reserved.

Source: https://www.marlerblog.com/case-news/we-all-of-us-need-to-rethink-how-we-produce-infant-formula-in-the-u-s-botulism-should-not-be-an-option/