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Regulatory UpdatesAug 25, 2026•1 min read

FDA Recalls Products Over Incorrect or Missing Lot and Expiration Dates

By the PharmaCountry team

The FDA has issued a recall for products with labeling errors, specifically incorrect or missing lot numbers and expiration dates that exceed the Beyond Use Date of at least one ingredient.

The U.S. Food and Drug Administration (FDA) has initiated a recall of certain pharmaceutical products because of labeling deficiencies. The affected items were found to have either incorrect or missing lot numbers and/or expiration dates. In addition, the Beyond Use Date (BUD) listed on the label exceeds the BUD or expiration date of at least one ingredient used in the final product, indicating a potential risk of reduced efficacy or safety. Manufacturers are required to remove the affected products from distribution and notify customers of the labeling issue. The recall underscores the importance of accurate labeling to ensure product integrity throughout the supply chain.

Compiled by the PharmaCountry team · Source: FDA.gov

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