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FDA recently released a warning letter dated September 5, 2025, issued to Fresh and Ready Foods LLC, a ready-to-eat (RTE) foods producer that was implicated in a multi-state, multi-year listeriosis outbreak.

Clostridium botulinum-contaminated ByHeart-brand formula has sickened at least 23 babies across 13 states. FDA inspection reports and warning letters have come to light showing a history of food safety and hygiene violations at the company’s production facilities.

A new analysis of U.S. Office of Personnel Management (OPM) data conducted by the National Sustainable Agriculture Coalition (NSAC) quantified the impact of federal workforce cuts on experts and inspectors within USDA-FSIS and USDA-APHIS.

The outbreak of infant botulism linked to ByHeart infant formula has grown to 23 confirmed cases in 13 states. All infants have been hospitalized, with no deaths reported. The company has issued a recall of all formula products sold nationwide.

ByHeart Inc., the infant formula manufacturer implicated in an ongoing, multistate botulism outbreak, has a history of food safety and hygiene violations at its production facilities, as well as an inadequate root cause analysis in previous incident, per FDA inspection records and warning letters.

The FY 2026 appropriations bill, approved by Senate to end the U.S. government shutdown, sets forth FDA’s Human Foods Program budget for FY 2026. It also prohibits the use of federal funds to enforce certain FSMA rules within designated timeframes or for specific commodities.

Taking place on November 18, the session will outline the traceability expectations of major retailers, wholesalers, and foodservice distributors, the implications for seafood suppliers, and how ReposiTrak can simplify end-to-end traceability—especially in light of FSMA 204.

The Reagan-Udall Foundation has published a report that captures key insights from stakeholder discussions on ways to improve U.S. infant formula safety and regulation, which were held to support FDA’s “Operation Stork Speed” efforts.

As of November 11, 15 infants have been hospitalized with botulism in 12 states after consuming ByHeart-brand powdered infant formula. The 15 infants who were confirmed to have consumed ByHeart are part of a broader outbreak comprising 84 total cases. A recall has been issued. 

Foreign food safety inspections conducted by FDA have hit a historic low due to Trump Administration budget and staff cuts, according to an investigative report by ProPublica.