Washington — The U.S. Food and Drug Administration has posted recall notices for nearly 113,000 bottles of Extra Strength Acetaminophen sold on Amazon, following consumer reports of discolored tablets.

The voluntary recalls, issued last month but only recently added to the FDA's enforcement report, affect 500-milligram caplets in three package sizes. The manufacturer, Aurobindo Pharma USA, is coordinating the action with Amazon and the FDA, a company spokesperson told USA Today.

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According to the FDA notices, the recalled lots include:

  • 14,640 bottles of 200-count, lot ACD125040A, exp. 09/30/2027
  • 90,456 bottles of 500-count, with lots ACD124036A, ACD124030A, ACD124042A, ACD124048B, and ACD125010A, expiring between 09/30/2027 and 02/29/2028
  • 7,836 bottles of 1,000-count, lot ACD124048A, exp. 11/30/2027

Consumers who purchased these products are urged to check the lot numbers and expiration dates printed on the label. If their bottle matches a recalled lot, they should stop using it immediately and contact Aurobindo Pharma for a refund or replacement.

Acetaminophen, the active ingredient in Tylenol and many generic pain relievers, is an analgesic and antipyretic — it reduces pain and fever by altering the body's pain perception and helping to cool it down, according to the National Institutes of Health's MedlinePlus.

This is not the first time Aurobindo has faced a recall over discolored pills. Last year, the company recalled 325-milligram acetaminophen tablets sold on Amazon after customers noticed a “brown surface on tablets.” In 2022, it pulled more than 160,000 bottles of Walgreens and Kroger brand acetaminophen due to child-resistant packaging defects.

The recalls come as Amazon's pharmacy business faces increased scrutiny. The company recently agreed to a $309 million settlement over return refund disputes, and a separate FTC settlement could lead to expanded payouts to consumers. Regulators have also been pressing Amazon on product safety, with the FDA monitoring recalls and enforcement actions.

Consumers who have questions about the recall can contact Aurobindo Pharma directly or visit the FDA's website for the full recall notices.