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  1. Recalls, Outbreaks & Emergencies

FDA Calls on Food Industry Leaders to Strengthen Recall Compliance and Ensure Recall Effectiveness

December 15, 2025

Dear Industry Leaders,

This letter is directed to manufacturers, packers, distributors, exporters, importers, and retailers involved in the manufacturing and distribution of human foods.

The U.S. Food and Drug Administration (FDA or we) is issuing this letter to remind industry of their legal responsibilities under the Federal Food, Drug, and Cosmetic Act (FD&C Act) with respect to food recalls. This letter also outlines best practices for ensuring effective recall compliance across the food supply chain.

Recalls are an important public health tool to remove violative (adulterated and/or misbranded) products, or products that present a risk of injury or gross deception or are otherwise defective, from the market, as outlined in 21 C.F.R. § 7.40(a). Effective recalls depend on every industry member in the supply chain taking prompt, thorough action. This letter builds upon FDA’s July 9, 2025 letter, FDA Encourages Food Industry Leaders to Streamline, Enhance Product Recall Communications With Public and Agency, and reflects FDA’s continued and steadfast commitment to our public health mission of food safety through radical transparency and improved communication. Recall timeliness and effectiveness is especially important when the recalled products are infant formula, baby foods, and foods intended for children – America's most vulnerable consumers.

Recent Recall Failures Identify Systemic Deficiencies

Recently, FDA, along with state and local partners, conducted over 4,000 checks at retail locations across the country following a recall of infant formula related to an outbreak of infant botulism. During these checks, we discovered that recalled product remained available for sale at over 175 retail locations across 36 states. In one case, recalled product remained available for sale over three weeks after the recall was initiated, and in another case, the recalled product was offered at a discounted price, with the promotional period beginning five days after the recall had been expanded to include all infant formula products from the manufacturer in question. In several cases, recalled product returned by consumers was placed back on shelves. These preventable situations placed America’s most vulnerable population—infants, for whom infant formula is often a sole source of nutrition—at continued risk of serious illness. FDA issued warning letters in December 2025 to several retailers citing failures to effectuate the recall of adulterated infant formula at their retail locations.

These concerns are not isolated to the recent infant formula recall. In late 2023, after a recall of Apple Cinnamon Fruit Puree pouches intended for children due to elevated lead contamination, one retailer continued to offer the adulterated products for sale despite multiple attempts by the agency urging the removal of products from store shelves, leaving children at risk of exposure to these adulterated products. FDA subsequently issued a warning letter to a retailer citing failures to effectuate the recall of lead-contaminated fruit puree pouches intended for children.

In both instances, the failure of these retailers to act swiftly left infants and children at risk of exposure to adulterated products. Some of the deficiencies FDA has observed during recall checks at the retail level include:

  • Lack of awareness of recalls:  some retailers were not aware that a recall had been issued for products in their inventory.
  • Lack of information to accurately identify all affected products:  some retailers were uncertain about which lot numbers or product codes were subject to the recall.
  • Incomplete removal of recalled items: even when aware of the recall, some retailers did not remove all affected products from shelves and storage areas.
  • Continued product distribution after recall notification:  some retailers continued to receive and stock recalled products after being notified of the recall, and some accepted customer returns of recalled products and returned them to inventory for resale.

While these failures to effectuate recalls mostly occurred at the retail level, they nonetheless signal systemic challenges that may exist across the industry. All members along the supply chain can and must do better to improve their processes for effectuating recalls in an effort to better protect U.S. consumers, and especially our most vulnerable consumers – our children.

Review of Mandatory Requirements and Recommended Best Practices

For facilities required to register with FDA under Section 415 of the FD&C Act

These facilities include establishments engaged in the manufacturing/processing, packing, or holding of food. Registered facilities are subject to the Preventive Controls for Human Foods regulation (21 CFR Part 117) and are required to establish and implement a written recall plan in accordance with 21 CFR 117.139 unless an exemption applies. The written recall plan must include procedures that describe the steps to be taken, and assign responsibility for taking those steps, to perform the following actions as appropriate to the facility (21 CFR 117.139(b)). This includes:

  • Direct consignee notification:  Directly notify the direct consignees of the food being recalled, including how to return or dispose of the affected food (21 CFR 117.139(b)(1)).
  • Public notification:  Notify the public about any hazard presented by the food when appropriate to protect public health (21 CFR 117.139(b)(2)).
  • Effectiveness verification:  Conduct effectiveness checks to verify that the recall is carried out (21 CFR 117.139(b)(3)).
  • Product disposition:  Appropriately dispose of recalled food—e.g., through reprocessing, reworking, diverting to a use that does not present a safety concern, or destroying the food (21 CFR 117.139(b)(4)).

FDA encourages you to review the Hazard Analysis and Risk-Based Preventive Controls for Human Food: Draft Guidance for Industry, Chapter 14: Recall Plan, which provides helpful information on how to best notify direct consignees with the specific information that they need to conduct the recall and how to clearly provide pertinent, descriptive information to enable accurate and immediate identification of the food being recalled [e.g., identify the product name, size, lot number(s), code(s), expiration dates, and any other pertinent descriptive information (such as UPC codes and shipping dates)].

For other firms in the recall product distribution chain, including retailers and distributors

Upon notification of a recall, downstream distributors and retailers should take all possible actions to immediately remove affected products from distribution and sale. We remind you that the receipt in interstate commerce of adulterated or misbranded food, and the delivery or proffered delivery thereof, is a violation of section 301(c) of FD&C Act (21 U.S.C. § 331(c)).

FDA encourages you to:

  • Collaborate with firms that are initiating the recall. Close collaboration ensures timely receipt of recall notifications and clear communication regarding product identification information and scope of the recall. Enhanced coordination across the supply chain can help prevent the patterns of recall ineffectiveness observed during recent checks.
  • Consider the establishment of a written recall plan to ensure recall effectiveness. While there are no specific statutory or regulatory requirements to establish a written recall plan for establishments that are not required to register with FDA under section 415 of the FD&C Act, we strongly encourage industry members to consider this as a best practice to ensure recall effectiveness. For example, such a written plan may include procedures that describe the steps to be taken, clear responsibility for taking those steps, and other actions necessary to ensure recall effectiveness.

For all industry stakeholders

Preparation is key when managing recalls. It is critical for firms to be “recall ready” so that they can act quickly and effectively to protect the public from violative products on the market.  We encourage industry to review guidances published by FDA, including Guidance for Industry and FDA Staff, Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C. Among other things, the guidance provides recommendations on appropriate and applicable preparations that firms in the product distribution chain should consider in advance of a potential recall.

Resources for Industry

Accountability for Effective Recalls

This letter reaffirms FDA’s call to action to the industry to strengthen all aspects of the recall process. Effective recalls require both clear communication and prompt, thorough action by all supply chain participants.

FDA, in collaboration with states and local partners, will continue to conduct retail checks and inspections to verify recall effectiveness. FDA will hold industry accountable and take appropriate action when firms fail to meet their legal obligations to remove recalled products from commerce.

Ultimately, it is the responsibility of all industry stakeholders involved in a recall, including retailers and distributors, to ensure that affected products are promptly removed from commerce and do not reach consumers.

Sincerely,

/S/

Donald A. Prater, DVM
Principal Deputy Director for Human Foods

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