FDA has not yet assigned a risk classification to the recall
Aurobindo Pharma USA Inc. has voluntarily recalled more than 112,000 bottles of Amazon-brand 500-milligram extra-strength acetaminophen following reports that consumers discovered discolored tablets in their bottles, according to a notice posted by the U.S. Food and Drug Administration. The manufacturer initiated the recall on Sept. 18.
The recall breaks down to three bottle sizes with specific lot numbers and expiration dates: 14,640 200-count bottles carrying lot number ACD125040A with an expiration date of Sept. 30, 2027; 90,456 500-count bottles with multiple lot numbers and expiration dates in 2027 and 2028; and 7,836 1,000-count bottles carrying lot number ACD124048A with an expiration date of Nov. 30, 2027.
The FDA has not yet issued a classification rating based on the level of health risk; the agency’s assessment of how consumers, retailers and physicians should treat the affected lots remains pending.
Amazon, which markets the product under its store brand, said in a statement to USA Today that the recall was carried out “in coordination with the manufacturer, Aurohealth, and the FDA.” The FDA recall notice identifies Aurobindo Pharma USA as the recalling firm.
Aurobindo issued a similar recall in 2025 for 325-milligram acetaminophen tablets also sold on Amazon, citing the same discoloration issue. That earlier recall involved a different tablet strength and a separate set of lots.