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 a notice posted by the Food and Drug Administration.
The recall, which was voluntarily initiated last month by manufacturer Aurobindo Pharma USA but only recently added to the FDA’s enforcement report, covers three separate product configurations. The affected lots include 14,640 bottles of 200-count caplets with lot number ACD125040A and an expiration date of Sept. 30, 2027; 90,456 bottles of 500-count caplets across multiple lot numbers and expiration dates; and 7,836 bottles of 1,000-count caplets with lot number ACD124048A and an expiration date of Nov. 30, 2027.
Amazon did not immediately respond to a request for comment from Nexstar, but a company spokesperson told USA Today that the recall is being carried out in coordination with Aurobindo and the FDA. The FDA’s enforcement report lists the reason for the recall as “discolored tablets,” a defect that can signal degradation or contamination but does not necessarily indicate a serious health risk.
Acetaminophen is a widely used analgesic and antipyretic, meaning it relieves pain and reduces fever. It is one of the most common over-the-counter medications in the United States and is sold under numerous brand names, including Tylenol, as well as generic store brands.
This is not the first time Aurobindo has faced quality issues with its acetaminophen products. Last year, the company issued a similar recall for 325-milligram acetaminophen tablets sold on Amazon after consumers noticed a “brown surface on tablets,” according to a company notice. In 2022, Aurobindo recalled more than 160,000 bottles of acetaminophen—approximately 137,300 units of Walgreens-brand acetaminophen and roughly 25,660 units of Kroger-brand arthritis pain acetaminophen—due to problems with child-resistant packaging.
The recurring recalls raise questions about quality control at Aurobindo, one of the largest suppliers of generic pharmaceuticals to the U.S. market. The FDA has not announced any additional regulatory action beyond the recall notices. Consumers who have purchased the affected products should check the lot numbers and expiration dates on their bottles and return them to Amazon or dispose of them according to local guidelines.
Amazon has faced scrutiny over product safety in the past. In recent years, the company has settled multiple cases with the Federal Trade Commission over issues ranging from refund disputes to subscription practices. As the dominant online retailer, Amazon’s handling of recalls is closely watched by regulators and consumer advocates.
The recall notice comes as the FDA continues to monitor the safety of over-the-counter medications sold through e-commerce platforms. While the agency does not have direct authority over Amazon’s marketplace, it works with manufacturers to ensure that defective products are removed from sale.
For now, the recall is limited to the specific lots listed in the FDA’s enforcement report. Consumers with questions can contact Aurobindo Pharma USA or the FDA’s MedWatch program.
