FOOD SAFETY NEWS – The same company whose infant formula is now under recall in relation to an outbreak of botulism poisoning cases recalled its product in 2022 because of contamination with cronobacter. And, in 2023, the FDA warned the company, ByHeart Inc., about unsanitary conditions at its production facility.
For the current outbreak, ByHeart infant formula has tested positive for botulism contamination. The outbreak has sickened a confirmed 13 babies across 10 states.
“ByHeart was notified by the FDA on Nov. 7, 2025, of an estimated 83 cases of infant botulism that were reported nationwide since August 2025. Of these, the FDA also noted that 13 infants received ByHeart formula at some point.
The FDA has not identified a direct link between any infant formula and these cases and there is no historical precedent of infant formula causing infant botulism,” according to the Food and Drug Administration.
The California Department of Public Health has tested ByHeart infant formula and found botulism contamination. The botulism in the formula matches a lab sample from one of the sick infants. The department and the FDA are recommending that people immediately stop using ByHeart infant formula.
Infant botulism is a very rare disease that occurs when babies inhale or swallow spores of the toxin-producing bacteria that cause infant botulism, which leads to progressive muscle weakness including trouble breathing if not treated in time.
ByHeart Inc. has initiated a recall of two lots of its infant formula: Lot 206VABP/251261P2 (“Use by 01 Dec 2026”) and Lot 206VABP/251131P2 (“Use by 01 Dec 2026”). ByHeart Whole Nutrition Infant Formula is available for sale online and at major retailers nationwide.
The warning letter
In an Aug. 2, 2023, warning letter the FDA ordered ByHeart owner Ron Belldegrun to clean up his infant formula production facility. The letter was in reference to a December 2022 through February 2023 inspection. Portions of the warning were redacted when it was made public.
“During our inspection at the (redacted) facility, 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”),” according to the warning letter.
In the letter, the FDA pointed out that the company had not established a system of process controls designed to ensure that infant formula in the production plant does not become contaminated with microorganisms. The FDA also noted that on Oct. 22, 2022, the company reported to (redacted) that a batch of ByHeart formula had tested positive for Cronobacter. Cronobacter can cause serious infections in babies that are often fatal.
At first, the positive test result showing contamination with Cronobacter was said to be a lab error, but further investigation showed this to not be the case.
“the third-party laboratory provided an ‘OOS Result Investigational Report for Microbiological Testing’ regarding the Cronobacter sakazakii findings in finished product, which concluded that ‘Laboratory error was not found or supported,’ “according to the warning letter.
“The third-party laboratory reached this conclusion after reviewing its internal protocols and testing conditions, finding no basis to attribute the sample results to laboratory error. Typically, a conclusion of lab error within an RCA is supported with confirmed evidence, such as written confirmation from the third-party laboratory attesting to the error. Here, there is no attestation; there is evidence to the contrary.
“Despite the discrepancy between the third-party laboratory and the internal conclusion within (redacted) root cause analysis, neither you nor your subsidiary company, (redacted), took any additional efforts to evaluate other routes of contamination that may have contributed to this event. Our review of your records obtained during the (redacted) inspection show that you did not work with your third-party contract manufacturer to further investigate the origin(s) or root cause(s) of the finished product positive findings. As the parent company and entity making all product disposition decisions, it is your 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(s) for a product contamination event.”
ByHeart did direct its third-party contractor to hold and destroy some formula that tested positive for cronobacter, but it released other formula finished product manufactured as part of its third-party contract manufacturer’s continuous production campaign.
“Upon further evaluation of (redacted) sanitation and production records, and following discussions with FDA, your firm subsequently conducted a voluntary recall of the remaining five lots of ByHeart Whole Nutrition Infant Formula, Milk Based Powder with Iron from the same Sept. 15, 2022, – Oct.7, 2022, campaign that you had previously released into U.S. commerce,” according to the warning letter.
The letter also states that ByHeart allowed the production of an infant formula base that had tested positive for cronobacter. “(Redacted) root cause analysis states: ‘[the SOP for] Interventions into Product Contact Zones was not followed during the work completed on back pressure valve FCV2700.
The exposure of a product contact surface to the environment such as a processing line post heat treatment (DSI) [direct steam injector] is highly risky, particularly when intervention procedures are not followed, and effective cleaning is not completed afterwards. This scenario poses the potential introduction of Cronobacter to the product processing stream.’ ”
Also, maintenance work and repair to the valve was not treated, verified, and recorded as an intervention into a product contact zone, as was required by standard operating procedures.
The FDA also cited problems with the company’s review of sanitation records.
“. . . the review did not appear to include an evaluation of the intervening sanitation breaks. Intervening sanitation breaks are a critical factor in assessing how a pathogen finding may impact product within a production campaign. (Redacted) ‘Event Reporting and Investigation Form’ Event Number 22107 does not contain an evaluation of the extent of the sanitation conducted and if it was sufficient to mitigate microbiological contamination from the system.”
The FDA acknowledged that ByHeart’s third-party lab provided the agency with whole genome sequencing (WGS) results on finished product that tested positive for cronobacter. However, the company did not conduct WGS analysis on all cronobacter isolates.
“In light of the timeframe between the production of the base product that was a component of the finished product you voluntarily recalled and the isolation of Cronobacter sakazakii in your infant formula base, further isolate analysis would have enabled your firm to have conducted a more comprehensive root cause analysis. Notably, your root cause analysis did not include any investigation of the available environmental isolates,” the FDA wrote in the warning letter.
“Further investigation of all these isolates, such as conducting WGS, would have provided more information about the potential role of your facility in contributing to the contamination event by indicating whether the strain of Cronobacter sakazakii found in finished product matched a strain of Cronobacter sakazakii previously detected at your (redacted) facility.
“WGS results could also indicate whether the same strain of Cronobacter sakazakii may be contributing to multiple contamination events, which would then inform the type of corrective action and verification activities you would need to perform to sufficiently remediate the contamination from your (redacted) facility following an intrusion event. We advised you of the importance of performing WGS on finished product and environmental isolates and comparing these results as part of a thorough root cause analysis via round table discussions on February 6, 2023 and May 9, 2023, as well as in FDA’s Letter to Industry on March 8, 2023.”
The FDA’s warning letter to ByHeart also took issue with testing that had shown problems in the production plant’s use of an ineffective sanitizer or ineffective cleaning frequency.
“While (redacted) listed possible sources of contamination in the Event Reporting Investigation Form, the root cause analysis did not include further investigation on the available environmental isolates, evaluation of water events in and around the time of the environmental detections, employee practices, material and equipment traffic, and hygienic practices. In addition, the investigation and root cause analysis did not evaluate the potential connection between these environmental positives and (redacted) infant formula base produced on Aug. 24 that tested positive for Cronobacter spp.
“Further, upon learning about the Oct. 17, 2022, finished product positive for Cronobacter sakazakii at your third-party contract manufacturer’s facility, which was blended using the infant formula base produced at the (redacted) facility between July 13 and Aug. 23, neither you nor (redacted) considered these environmental positives as potentially contributing to that contamination event.”
In its warning letter, the FDA references at least two times when water leaked from outside the building into manufacturing areas. After the leaks ByHeart was notified by its third-party lab that cronobacter was found in the processing environment for the company’s infant formula.
“Despite having a leak in June and a notification the following month of product testing positive for Cronobacter sakazakaii, the root cause analysis never considered or evaluated whether the leak may have contributed to the contamination,” according to the FDA in reference to a leaking skylight.
For a leak in a seal around a dryer tower, the FDA noted that a worn sealant around the frame of the inlet louver and heavy wind and rain all day on Dec. 15, 2022, caused the leak. During environmental swabbing conducted on the same day four swabs detected Cronobacter spp. in the dryer tower and the area around it.
“Despite having a leak in December and then detecting Cronobacter spp. via environmental swabbing following the leak, the root cause analysis never considered or evaluated whether the leak may have contributed to the contamination,” the FDA warning letter states.
The FDA said in its warning letter that wet conditions in the production plant either intentionally as part of wet cleaning, or inadvertently as the result of leaking pipes or valves or roofs – are especially favorable for the growth of Cronobacter.
The FDA also told the company that it had found it had released product that had been found to have been contaminated, which is a violation of federal law.
“On Oct. 15, 2022, you notified your third-party contract manufacturer that ByHeart Whole Nutrition Infant Formula finished product, tested positive for Cronobacter sakazakii. The campaign for this product was blended at your third-party contract manufacturer’s facility between Sept. 15-20, 2022, and then packaged between Sept. 30-Oct. 7, 2022. In response to the positive Cronobacter sakazakii findings, you directed your third-party contract manufacturer as to which lots of the continuous production campaign should be destroyed and which lots should be released for distribution into interstate commerce. While the lot that tested positive for Cronobacter sakazakii and the first pallet of the subsequent lot were held and destroyed per your instructions, the other lots manufactured as part of the same Sept. 30-Oct. 7, 2022 campaign were released.
“When conducting the root cause analysis for the contamination and making your product disposition decisions, you did not evaluate production records or consider intervening sanitation breaks as a factor. Following FDA’s review of your contract manufacturer’s records and lack of intervening sanitation breaks, FDA determined that your firm released adulterated powdered infant formula into U.S. commerce.”
(To sign up for a free subscription to Food Safety News, click here)
