Nearly 113,000 bottles of 500-milligram Extra Strength Acetaminophen caplets sold through Amazon are being pulled from the market after consumers reported finding discolored tablets, according to enforcement notices posted by the Food and Drug Administration.
The recall was initiated voluntarily last month by manufacturer Aurobindo Pharma USA but only surfaced in the FDA's enforcement report in recent days. Amazon, which did not immediately respond to a request for comment, told USA Today that the action is being carried out jointly with Aurobindo and the FDA.
The FDA's website lists three separate alerts covering different package sizes and lot numbers. The largest covers 90,456 bottles of 500-count caplets with multiple lot numbers and expiration dates ranging from September 2027 through February 2028. Another alert covers 14,640 bottles of 200-count caplets, and a third involves 7,836 bottles of 1,000-count caplets. All are 500-mg extra-strength products.
According to the notices, the recall was triggered by customer reports of discolored pills. Acetaminophen, widely known by the brand name Tylenol, is an analgesic and antipyretic used to relieve pain and reduce fever. The discoloration does not necessarily indicate a loss of potency or a new safety risk, but the FDA's public posting signals that the agency considers the issue serious enough to warrant a formal enforcement action.
This is not Aurobindo's first recall of acetaminophen sold online. Last year, the company issued a similar recall for 325-milligram tablets sold on Amazon after consumers noticed a brown surface on the pills. In 2022, Aurobindo recalled more than 160,000 bottles of acetaminophen—including Walgreens and Kroger store-brand products—over problems with child-resistant packaging.
The recurring nature of these recalls raises questions about quality control at Aurobindo, one of the largest generic drug manufacturers supplying the U.S. market. The FDA has not issued a public warning about the affected lots beyond the standard enforcement report, but consumers who purchased the products should check lot numbers and consult the agency's notice.
The recall also highlights the growing role of Amazon as a pharmacy and over-the-counter drug retailer. The company has faced increased scrutiny over product safety and regulatory compliance in recent years, including a $309 million settlement over return refund disputes and a $2.5 billion FTC settlement that expanded payouts to consumers. As Amazon expands its healthcare footprint, recalls of this kind will test its ability to manage supplier quality and communicate risks to customers.
For now, the FDA's action is limited to specific lots of Aurobindo's 500-mg acetaminophen. Consumers who find discolored tablets in bottles matching the recalled lot numbers should stop using them and return them to Amazon or contact Aurobindo for a refund or replacement.
