Nearly 113,000 bottles of a popular pain reliever sold through Amazon are being pulled from the market after customers reported finding discolored tablets, federal regulators said this week.
The voluntary recalls, issued last month but only recently logged in the U.S. Food and Drug Administration's enforcement database, cover three lots of 500-milligram Extra Strength Acetaminophen caplets distributed by Aurobindo Pharma USA. The action affects roughly 14,640 bottles in 200-count sizes, 90,456 bottles in 500-count sizes, and 7,836 bottles in 1,000-count sizes, according to the FDA notices.
Consumers flagged the problem after opening the bottles and seeing pills that had changed color, the recall alerts state. The discoloration could indicate a degradation of the active ingredient, though no adverse health events have been reported so far.
Amazon, which sold the affected product directly through its platform, said it is coordinating the recall with Aurobindo and the FDA. A company spokesperson told USA Today that the e-commerce giant is notifying customers who purchased the affected lots and offering refunds or replacements.
This is not the first time Aurobindo has faced quality complaints tied to Amazon sales. In 2023, the company recalled 325-milligram acetaminophen tablets after users noticed a “brown surface on tablets.” Two years earlier, Aurobindo pulled more than 160,000 bottles of store-brand acetaminophen sold at Walgreens and Kroger because child-resistant packaging failed to meet safety standards.
Acetaminophen, widely used to relieve pain and reduce fever, is one of the most common over-the-counter drugs in the United States. The FDA's enforcement reports are routinely scrutinized by consumer safety advocates, especially when online retail giants like Amazon are involved. The company has faced other regulatory headaches recently, including a $309 million settlement over return refund disputes and a $2.5 billion FTC settlement over privacy violations.
For consumers, the recall underscores the importance of checking lot numbers and expiration dates on medication bottles. The affected lots include ACD125040A, ACD124036A, ACD124030A, ACD124042A, ACD124048B, ACD125010A, and ACD124048A, with expiration dates ranging from September 2027 to February 2028.
The FDA advises anyone with the recalled product to stop using it immediately and return it to the place of purchase or contact Aurobindo for a refund. The agency also encourages consumers to report any adverse reactions through its MedWatch program.
Amazon's role in the recall highlights the growing scrutiny of online pharmacy sales, as regulators push for stricter oversight of third-party sellers and fulfillment channels. Lawmakers have also pressed for stronger consumer protections in the digital marketplace, with some Senate Democrats demanding tariff refunds in unrelated trade disputes.
