Amazon Recalls 112,000 Bottles of Acetaminophen Over Discolored Pills; FDA Investigates

Amazon has pulled more than 112,000 bottles of its store-brand extra-strength acetaminophen from the market after consumers reported discolored caplets, the Food and Drug Administration announced this week. The voluntary recall, initiated Sept. 18 by manufacturer Aurobindo Pharma USA, covers three package sizes of Amazon Basic Care Extra Strength Pain Relief 500 mg caplets distributed nationwide through Amazon.com Services LLC.

Consumers should immediately check bottles against the affected lot numbers and stop using any matching product. The recall encompasses 14,640 bottles of the 200-count size (lot ACD125040A), 90,456 bottles of the 500-count size (lots ACD124036A, ACD124030A, ACD124042A, ACD124048B, ACD125010A), and 7,836 bottles of the 1,000-count size (lot ACD124048A). All were manufactured in India by Aurobindo subsidiary Aurohealth.

Tablet discoloration can signal chemical degradation, moisture exposure, or contamination during manufacturing — any of which may reduce potency or introduce impurities. While the FDA has not identified a specific health hazard or received injury reports, the agency classifies such recalls as Class II when the product could cause temporary or medically reversible adverse effects. Acetaminophen degradation products, including 4-aminophenol, can be toxic at elevated levels.

“Amazon is voluntarily recalling specific lots due to reports of tablet discoloration in the affected lots,” a company spokesperson confirmed, adding that the retailer is coordinating with Aurohealth and federal regulators. Customers who purchased the affected lots are eligible for full refunds and should contact Amazon customer service for return instructions.

The recall follows a separate Sept. 3 action by India-based Inventia Healthcare Ltd., which withdrew 13,567 bottles of 25 mg chlorthalidone tablets after they failed dissolution testing — a critical quality measure ensuring the drug releases properly in the body. Both recalls involve Indian manufacturing facilities supplying the U.S. generic drug market, where the FDA has increased inspection frequency in recent years following data-integrity concerns at several plants.

Pharmacists recommend that patients using acetaminophen for chronic conditions consult a healthcare provider before abruptly switching products, as consistent dosing matters for pain management. For occasional use, consumers can substitute any FDA-approved 500 mg acetaminophen product from an unaffected lot or manufacturer. The FDA maintains a searchable recall database at fda.gov/safety/recalls where lot numbers can be verified.

Aurobindo Pharma USA, headquartered in Dayton, New Jersey, is the U.S. arm of one of India’s largest generic drugmakers. The company has faced previous FDA warning letters citing manufacturing deficiencies. The current recall remains ongoing, and the agency says it is evaluating whether the discoloration stems from a stability issue, packaging defect, or raw-material problem.