On 29 September 2023, the US Food and Drug Administration (FDA) proposed to implement infant formula recall regulations with a comment deadline of 30 October 2023, with the aim of establishing statutory requirements for infant formula to protect the health of infants and to implement current Good Manufacturing Practices (GMPs), labelling, and a number of reporting and record-keeping requirements. 

When recalling infant formula, manufacturers shall:

(1) Assess the risk to human health;

(2) Develop a written recall strategy;

(3) promptly notify each affected direct customer (client) of the recall;

(4) Provide copies of relevant documents to the appropriate FDA district office. 

If the recalled formula poses a risk to human health, the manufacturer responsible for the recall must require the distribution unit of the recalled formula to issue a recall notice and provide a copy of the notice to FDA.

The manufacturer responsible for the recall shall:

(1) Notify the appropriate FDA district office of the recall by telephone within 24 hours;

(2) Submit a written report to the FDA regional office within 14 days;

(3) Submit written status reports at least every 14 days until the recall is terminated. The recalling company shall retain sales records for at least 1 year after the expiration of the shelf life of the infant formula.