Multiple lots of finished ByHeart product have tested positive for Clostridium botulinum Type A. The outbreak strain of C. botulinum was also detected in an open can of formula collected from a patients’ home and tested by the California Department of Public Health (CDPH).

Since the outbreak came to light, ByHeart has come under increasing scrutiny for a history of food safety failures. FDA inspections found mold, dead insects, and leaking roof issues at its Reading, Pennsylvania facility (now closed), as well as rodent activity, rusty surfaces, and Cronobacter sakazakii-positive environmental swabs at the company’s Fullerton, Iowa plant. ByHeart was also one of three infant formula manufacturers that received warning letters from FDA in September 2023 due to the positive tests for C. sakazakii and for not establishing a “system of process controls covering all stages of processing that was designed to ensure that infant formula does not become adulterated due to the presence of microorganisms in the formula or in the processing environment,”

Notably, despite the nationwide recall, FDA found ByHeart formula products on store shelves at more than 175 locations across 36 states as late as three weeks following the recall. FDA subsequently issued warning letters to Target, Walmart, Kroger, and Albertsons regarding the failure to remove ByHeart products from their stores. The agency also issued a letter to industry reminding firms of their responsibilities in the case of a recall.

Senator Demands Answers from ByHeart Inc.

In his letter to ByHeart Inc., Senator Cassidy wrote, “I am concerned about the release of inspection reports finding that ByHeart facilities had numerous safety deficiencies, including failing to take steps to limit contamination or adulteration of product manufactured in those facilities.” He requested answers to the following questions by January 14, 2026:

1. When did ByHeart first become aware of safety concerns regarding its infant formula?
2. How is ByHeart engaging with retailers to ensure that any recalled infant formula batches are no longer being sold?
3. How is ByHeart engaging with state and federal entities to limit any supply chain impact associated with ByHeart’s safety recall?
4. What safety processes, including testing frameworks, does ByHeart have in place to ensure infant formula products are safe?
   1. Does ByHeart work with any third-party entities to review and improve safety processes?
   2. Does ByHeart conduct any proactive inspection of its facilities?
   3. In the last five years, has ByHeart identified any safety hazards at its facilities in Allerton, Iowa; Portland, Oregon; or Reading, Pennsylvania? If so, please provide a list of any identified hazards and steps ByHeart took to address those hazards.
5. FDA recently released records for inspections conducted between 2022 and March 2025 finding non-compliance with requirements for good manufacturing practices (GMPs), including “Not maintaining a building used in the manufacture, processing, packing or holding of infant formula in a clean and sanitary condition.” 

1. Between 2022 and March 2025, how many GMP deficiencies did FDA note as part of their inspections? Please provide a list of each identified deficiency.
2. For each identified deficiency, please provide a list of how ByHeart resolved those deficiencies.

6. Has ByHeart voluntarily removed any infant formula batches manufactured in the U.S. sold in foreign markets?

1. Has ByHeart received any engagement regarding safety with foreign product regulators?