FDA Calls for Industry to Strengthen Recall Programs

FDA's letter, which was signed by the Principal Deputy Director for Human Foods, builds on the agency's July 9, 2025 letter addressing recall communications for infant and children's products.²  FDA reports that the more than 4,000 retail checks conducted for the recent infant formula recall identified recalled infant formula products available for sale at over 175 retail locations across 36 states. The letter reports that FDA issued warning letters in December 2025 to several retailers “citing failures to effectuate the recall of adulterated infant formula at their retail locations.”

FDA characterizes these observations as preventable and as posing serious risks to infants. The agency cites multiple examples of recall breakdowns at the retail level, including products remaining on shelves weeks after recall initiation, recalled products being discounted, and returned products being restocked. FDA also references similar failures during the 2023 recall of apple cinnamon fruit puree pouches due to elevated lead levels, which also resulted in a warning letter. Additionally, FDA identifies recurring issues that contribute to ineffective recalls, including lack of awareness of recalls, insufficient product identification information, incomplete removal of affected products, and continued distribution or resale of recalled products.

FDA reiterates that effective recalls require prompt action and clear communication throughout the supply chain. The agency says it will continue to conduct retail checks and inspections and may take enforcement action where firms fail to meet legal requirements. FDA stresses that all participants in the supply chain—including retailers and distributors—share responsibility for ensuring recalled products are removed from commerce. FDA also urges firms to be “recall ready” and directs industry to existing guidance addressing recall preparedness, including advance planning, personnel training, distribution recordkeeping, and product coding. FDA’s letter highlights its general recall guidance webpage and draft Preventive Controls guidance addressing recall plans.³

FDA explains the following requirements and expectations for different components of the supply chain:

• Requirements for Registered Facilities: Facilities required to register under Section 415 of the FD&C Act and subject to the Preventive Controls for Human Food regulation (21 CFR Part 117) must establish and implement written recall plans consistent with 21 CFR § 117.139. Required elements include procedures for notifying consignees, public notification where appropriate, effectiveness checks, and proper disposition of recalled products. FDA also recommends that such facilities review draft guidance on best practices for providing clear and complete recall notifications.⁴
• Expectations for Retailers and Distributors: FDA reminds distributors and retailers that the receipt or delivery of adulterated or misbranded food violates Section 301(c) of the FD&C Act. While retailers and distributors are not generally required to maintain written recall plans, FDA strongly encourages them to do so and to coordinate closely with recalling firms to ensure timely notice and accurate product identification.

In closing, FDA encourages all of industry to collaborate with the firms initiating a recall. The agency emphasizes that “preparation is key when managing recalls” so that firms can quickly and effectively remove recalled products from the market. FDA says that the agency, in collaboration with state and local partners, will continue to conduct recall checks and inspections to verify recall effectiveness, and will hold industry accountable when firms fail to meet their legal obligations to remove recalled products from commerce.

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We will continue to monitor FDA's recall policies and enforcement activity. If you would like to discuss how you can evaluate the strength of your recall program or have any other questions, please do not hesitate to contact us.

Authored by Maile Gradison and Noah Brown.