Pharmaceutical manufacturer Aurobindo Pharma USA Inc. has recalled more than 112,000 bottles of generic acetaminophen pain relievers sold across the United States on Amazon.
The nationwide recall was launched after the company received complaints from consumers who reported that the tablets were discolored.
The recall affects 112,932 bottles of 500-milligram generic acetaminophen tablets packaged in 200-count, 500-count, and 1,000-count bottles with expiration dates reaching up to February 2028.
Although Aurobindo Pharma first initiated the recall on September 18, the affected lots were not published in the Food and Drug Administration's online recall database until Monday.
No illnesses have been reported to date in connection with the recalled medication, and federal regulators at the FDA have not yet assigned an official risk level to the recall.
Health authorities have not issued specific consumer guidance for this recall. In previous acetaminophen recalls, regulatory authorities advised consumers not to consume the affected tablets and to return them to the seller for a full refund.
Recalled bottle counts and lot numbers
The recall covers three distinct bottle sizes sold nationwide through Amazon, each identified by specific lot numbers located near the barcode.
The largest portion of the recall consists of 90,456 500-count bottles. These bottles have expiration dates ranging from September 2027 to February 2028 and bear lot codes ACD124036A, ACD124030A, ACD124042A, ACD124048b, and ACD125010A.
A total of 14,640 200-count bottles are also included in the recall. These containers bear the lot code ACD125040A and have a best-by date of September 2027.
An additional 7,836 1,000-count bottles are subject to the recall. These carry the lot code ACD124048A and an expiration date of November next year.
Medication discoloration and quality risks
The recall notification did not specify what caused the tablets to become discolored, and no additional details regarding the underlying issue were provided.
Discoloration in pharmaceutical tablets can indicate that a drug has degraded or changed from its intended formulation. Color changes are commonly caused by environmental factors such as moisture or heat exposure, chemical degradation, or manufacturing flaws.
When medications develop abnormal coloration, regulatory standards dictate that they may no longer satisfy required health and safety specifications.
Previous recalls and regulatory history
This incident is not the first time Aurobindo Pharma has recalled acetaminophen due to tablet discoloration.
In 2025, the pharmaceutical manufacturer recalled 4,608 bottles of generic acetaminophen tablets sold through Amazon following consumer reports of a brown surface on tablets. The FDA designated that action as a Class II recall, which applies to situations where exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where serious health risks are remote.
Aurobindo Pharma has also faced scrutiny from federal regulators regarding its production facilities. The FDA issued warning letters to the company in 2019 and 2022 citing significant deviations from current good manufacturing practice after inspecting two of its factories in India.
Usage of generic acetaminophen in the US
Acetaminophen is one of the most widely used over-the-counter pain relievers and fever reducers in the United States. Public health estimates show that approximately 20 percent of American adults, or one in five, take an acetaminophen-containing medicine in any given week.
The drug is used to treat everyday conditions such as headaches, muscle aches, back pain, menstrual cramps, and fever. Generic acetaminophen is produced by multiple pharmaceutical manufacturers and distributed across major retail chains and e-commerce platforms.
Aurobindo Pharma USA Inc. is the US subsidiary of India-based Aurobindo Pharma Limited, a major pharmaceutical firm that manufactures generic medications and active pharmaceutical ingredients for international markets.
