The Amazon acetaminophen recall covers 112,932 bottles of extra-strength 500mg caplets distributed across the United States. Aurobindo Pharma initiated the voluntary action following complaints about discolored tablets. Consumers should check affected lot numbers and expiration dates.

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More than 112,000 bottles of Amazon-branded extra-strength acetaminophen have been recalled across the United States following customer complaints about discolored tablets, according to the U.S. Food and Drug Administration (FDA).

The voluntary recall covers 112,932 bottles of 500-milligram caplets distributed through Amazon.

Why was Amazon acetaminophen recalled?

Aurobindo Pharma USA Inc. initiated the recall on September 18, 2026, after receiving complaints about tablet discoloration. The FDA published the recall details on October 2, 2026.

Acetaminophen is an over-the-counter medication commonly used to relieve pain and reduce fever. The recall applies to specific batches of Amazon-branded Extra Strength Acetaminophen, not all acetaminophen products sold nationwide.

Recalled acetaminophen lot numbers and expiration dates

The FDA identified seven affected lots across three bottle sizes:

The recall includes 14,640 bottles containing 200 caplets, 90,456 bottles containing 500 caplets, and 7,836 bottles containing 1,000 caplets.

What has the FDA said about the medication recall?

As of October 14, 2026, the FDA had not assigned a health-risk classification to the recall, which remained ongoing.

No adverse health effects had been reported in the available recall coverage. However, the absence of reported injuries does not establish that affected medication is safe to use.

What should customers do with recalled bottles?

Consumers who purchased Amazon Basic Care Extra Strength Pain Relief should check their bottles for the affected lot numbers and expiration dates.

Customers with recalled products should stop using them and contact Amazon customer service for assistance with a return or refund.

Anyone needing alternative pain or fever medication can consult a pharmacist or healthcare professional.

The recall remains active while the affected products are being addressed. Consumers should use the FDA's enforcement information to verify their medication rather than relying on its appearance alone.