The recall was initiated on September 18, 2026, by Aurobindo Pharma USA, a pharmaceutical company based in New Jersey. According to the U.S. Food and Drug Administration (FDA), the affected products were manufactured in India and distributed nationwide by Amazon.com Services LLC. The agency has not identified the cause of the discoloration or reported whether any injuries are associated with the affected medication.
More Than 112,000 Bottles Affected Across Three Package Sizes
The FDA’s recall database identifies 112,932 bottles of Amazon Extra Strength Acetaminophen 500 mg caplets across three package sizes. The largest portion involves 90,456 bottles containing 500 caplets each, followed by 14,640 bottles containing 200 caplets and 7,836 bottles containing 1,000 caplets.
Each package size has specific manufacturing lot numbers listed in the federal recall notice. The 200-count bottles are identified by lot ACD125040A, with an expiration date of September 30, 2027.
Five lots are affected among the 500-count bottles: ACD124036A, ACD124030A, ACD124042A, ACD124048B and ACD125010A. Their expiration dates range from September 30, 2027, through February 29, 2028. The 1,000-count bottles are associated with lot ACD124048A, which carries an expiration date of November 30, 2027.
According to the FDA, all three products were recalled for the same stated reason: consumer complaints involving discolored tablets. The agency’s records do not specify how many complaints were received or describe the appearance of the discoloration.
The affected medications were distributed under Amazon branding, with Amazon.com Services LLC listed as the distributor at its Seattle, Washington, address. The recall applies to products distributed throughout the United States.
FDA Investigation Leaves Cause of Tablet Discoloration Unspecified
Amazon confirmed the recall in a statement provided to FOX Business, identifying the affected medication as Amazon Basic Care Extra Strength Pain Relief acetaminophen 500 mg caplets.
“Amazon is voluntarily recalling specific lots of Amazon Basic Care Extra Strength Pain Relief acetaminophen 500mg caplets due to reports of tablet discoloration in the affected lots,” an Amazon spokesperson told the publication.
The company also said the action was being coordinated with the manufacturer, Aurohealth, and the FDA. Federal records identify Aurobindo Pharma USA Inc., located in East Windsor, New Jersey, as the recalling firm. The FDA lists the recall as voluntary and ongoing, with the initial notification issued by letter.
The agency has not yet assigned a recall classification to the affected products. Its public listing also contains no termination date or separate press release for the recall. According to FOX Business, the FDA has not described any specific health risks associated with the discolored tablets or indicated whether injuries have been reported.
The acetaminophen recall follows another voluntary pharmaceutical recall initiated September 3 by India-based Inventia Healthcare Ltd. That separate action involved 13,567 bottles of 25-milligram chlorthalidone tablets that failed to meet dissolution specifications. For the Amazon acetaminophen products, the FDA’s published records continue to identify tablet discoloration as the reason for the recall, without establishing its underlying cause.
