Amazon Recalls Extra Strength Acetaminophen Bottles Over Discolored Tablets

More than 112,000 bottles of Amazon-branded Extra Strength Acetaminophen are being recalled after consumers reported discolored tablets, according to a U.S. Food and Drug Administration recall notice. Aurobindo Pharma USA Inc. initiated the voluntary recall for medication sold nationwide through Amazon.

The recall covers 112,932 bottles of 500-milligram acetaminophen caplets distributed by Amazon.com Services LLC, according to FDA records. The agency said the recall was prompted by customer complaints about tablets appearing discolored.

The affected products include 200-count, 500-count and 1,000-count bottles of Amazon-branded Extra Strength Acetaminophen. The FDA has not assigned a classification indicating the level of health risk associated with the recall.

Amazon said the recall was carried out with the manufacturer and federal regulators.

"The recall was done in coordination with the manufacturer, Aurohealth, and the FDA." Amazon said.

Aurobindo Pharma USA Inc. manufactured the recalled medication, which contains acetaminophen, a common over-the-counter drug used to relieve pain and reduce fever. The company did not immediately respond to requests for comment from USA TODAY.

The recalled 200-count bottles include lot ACD125040A with an expiration date of September 30, 2027. The recalled 500-count bottles include lots ACD124036A, ACD124030A, ACD124042A, ACD124048B and ACD125010A with expiration dates ranging from September 30, 2027, to February 29, 2028.

The recalled 1,000-count bottles include lot ACD124048A with an expiration date of November 30, 2027, according to the FDA notice. Consumers with affected products were advised by officials to seek guidance from pharmacists or healthcare providers.

Acetaminophen has also faced separate safety discussions in recent years. The FDA previously noted research involving possible links between acetaminophen use during pregnancy and neurological conditions, while saying a causal relationship had not been established.

"May be associated" was the wording used in studies discussing possible risks related to acetaminophen use during pregnancy, according to reporting from Yahoo.

The FDA's September 2025 report addressed research findings involving acetaminophen and autism-related outcomes.

"While an association between acetaminophen and autism has been described in many studies, a causal relationship has not been established." the FDA said.

The current recall remains focused on the discolored tablets reported by consumers. The FDA notice published details of the affected lots and stated that no health risk classification had been assigned at the time of the recall.