Full Breakdown
Amazon Recalls More Than 112,000 Bottles of Private-Label Extra-Strength Acetaminophen
By Drooid · · How we work
Recall Overview
The U.S. Food and Drug Administration (FDA) announced a voluntary recall of Amazon-branded extra-strength acetaminophen after consumers reported discolored tablets. The recall, initiated by the drug’s manufacturer Aurobindo Pharma USA, covers three bottle sizes—200-count, 500-count, and 1,000-count caplets. The FDA has not assigned a health-risk classification to the recall and has not reported any injuries linked to the discoloration.
Scope and Product Details
- Total bottles affected: more than 112,000.
- Bottle counts: approximately 14,640 bottles of 200 caplets, 90,456 bottles of 500 caplets, and 7,836 bottles of 1,000 caplets.
- Lot numbers: 200-count (ACD125040A); 500-count (ACD124036A, ACD124030A, ACD124042A, ACD124048B, ACD125010A); 1,000-count (ACD124048A).
- Manufacturing origin: India.
- Distribution: Amazon.com Services LLC, Seattle, Washington.
The FDA’s notice cites consumer complaints of tablet discoloration as the trigger for the recall but does not identify the cause of the discoloration.
Background and Related Recalls
The acetaminophen recall follows a separate voluntary recall announced earlier in September involving Inventia Healthcare Ltd., an India-based company, which withdrew more than 13,500 bottles of 25-mg chlorthalidone tablets for failing dissolution specifications. Both actions illustrate heightened FDA scrutiny of pharmaceutical products sold through online marketplaces.
Official Statements and Consumer Guidance
An Amazon spokesperson confirmed the voluntary recall, stating that the company is working with the manufacturer and the FDA. The FDA advises customers who possess the recalled product to check the lot numbers on their bottles and contact Amazon customer service for a remedy. No specific health risks have been communicated, and the agency has not indicated that the discoloration poses a safety hazard.
Consumer Impact and Next Steps
Consumers are urged to locate the affected lot numbers on any Amazon-branded extra-strength acetaminophen bottles they own and follow Amazon’s return or refund procedures. The recall remains ongoing, and the FDA will continue to monitor the situation for any emerging safety information.
