In a December 15, 2025 press release, the U.S. Food and Drug Administration reminded industry of its legal responsibilities under the Federal Food, Drug, and Cosmetic Act regarding food recalls and called for industry to increase adoption of best practices in recall implementation.

Last week, the FDA sent warning letters to several major retailers for failing to remove recalled ByHeart infant formula from their store shelves despite being notified of the recall. These warning letters highlight a concerning problem with recall effectiveness at the retail level. Last year, the FDA sent a similar warning letter to a retailer who failed to adequately remove recalled lead-contaminated WanaBana apple cinnamon fruit puree pouches from its store shelves.

In the weeks following the manufacturer’s voluntary recall of ByHeart infant formula products, FDA investigators and state and local partners checked retail stores across the U.S. over 4,000 times to ensure recalled product was not being made available to consumers. The investigation discovered recalled infant formula continued to be found on store shelves—for over three weeks in one case, in over 175 locations across 36 states. These warning letters highlight the critical responsibility that retailers have in effectuating a recall, particularly when dealing with products that pose serious health risks to our most vulnerable populations, such as infants.

The FDA has asked these retailers to respond to the warning letters within 15 days stating the specific steps they have taken to address any violations and prevent the recurrence of violations, or providing its reasoning and supporting information as to why the company believes it is not in violation of the law.