Overview
- Aurobindo Pharma USA initiated a voluntary recall on Sept. 18 covering about 112,932 bottles of Amazon-branded extra-strength 500 mg acetaminophen sold in 200-, 500- and 1,000-count bottles.
- The recall targets specific lot numbers and expiration dates, including 14,640 200-count bottles, 90,456 500-count bottles across several lots, and 7,836 1,000-count bottles with listed lot IDs and expiry dates.
- The action was prompted by customer reports of discolored tablets in the affected bottles, and the FDA says the recall remains ongoing while it reviews the matter.
- Aurobindo did not immediately respond to reporters’ requests for comment, and Amazon told one outlet the recall is voluntary and coordinated with the manufacturer and the FDA.
- No adverse events tied to the recalled lots have been reported in the coverage and consumers are being directed to the FDA enforcement notice to check lot numbers and follow return or disposal instructions.