Over 112,000 Bottles of Acetaminophen Recalled on Amazon for Discoloration

India-based Aurobindo Pharma USA Inc. has voluntarily recalled more than 112,000 bottles of its generic acetaminophen pain reliever sold on Amazon due to quality concerns. The recall was initiated after consumers reported that the tablets were discolored.

The affected product is acetaminophen 500 milligrams, sold in 200-, 500-, and 1,000-count bottles with best-by dates up to February 2028. The recall encompasses 90,456 500-count bottles with lot codes ACD124036A, ACD124030A, ACD124042A, ACD124048b, and ACD125010A, and expiration dates ranging from September 2027 to February 2028. Additionally, 14,640 200-count bottles with lot code ACD125040A and a September 2027 best-by date, along with 7,836 1,000-count bottles with lot code ACD124048A and a November 2027 best-by date, are included.

The Food and Drug Administration (FDA) was notified of the recall on September 18, but the product was not listed in the agency's recall database until October 7. No illnesses have been reported in connection with this recall, and the FDA has not assigned a risk level to it.

Discoloration in medication can indicate degradation, chemical changes, or manufacturing issues, suggesting the product may not meet required standards. The specific cause for the discoloration in these acetaminophen tablets was not detailed in the recall notice.

This is not the first time Aurobindo Pharma has recalled acetaminophen tablets due to discoloration. In 2025, the company recalled 4,608 bottles of its generic acetaminophen sold on Amazon after receiving similar complaints of brown-colored tablets. That recall was classified as a Class II recall, indicating a situation that could cause temporary or medically reversible adverse health consequences.

Aurobindo Pharma has previously faced regulatory scrutiny. The FDA issued warning letters to the company in 2019 and 2022, citing deviations from current good manufacturing practices after inspections of two of its manufacturing facilities in India.

Acetaminophen is a widely used over-the-counter medication in the United States, with an estimated 20 percent of American adults taking an acetaminophen-containing product weekly. It is commonly used to reduce fever and alleviate everyday pain such as headaches, muscle pain, and menstrual cramps.