More than 112,000 bottles of Amazon-branded Extra Strength Acetaminophen 500 mg caplets are included in a voluntary recall prompted by consumer reports of discolored tablets, according to the Food and Drug Administration. The recall was initiated Sept. 18 by Aurobindo Pharma USA and remains ongoing, the FDA says.
The affected packages include 14,640 bottles of 200 caplets, 90,456 bottles of 500 caplets and 7,836 bottles of 1,000 caplets. The FDA information cited in the source does not explain what caused the discoloration or describe specific health risks. It also does not say whether any injuries have been reported.
The FDA-listed lot numbers are ACD125040A for 200-count bottles; ACD124036A, ACD124030A, ACD124042A, ACD124048B and ACD125010A for 500-count bottles; and ACD124048A for 1,000-count bottles.
Amazon confirmed the voluntary recall and said it was coordinating with the manufacturer and federal regulators. The products were manufactured in India and distributed by Amazon.com Services LLC, according to the source report.
