Indian Company Recalls 113,000 Bottles of Acetaminophen Sold Through Amazon

Medications for sale at a pharmacy in Los Angeles on May 12, 2025. Eric Thayer/Getty Images

More than 100,000 bottles of generic acetaminophen sold through Amazon were recalled by an India-based manufacturer due to consumer complaints about discoloration, according to notices published on the Food and Drug Administration’s website this past week.

The recall impacts Amazon acetaminophen caplets in 500-milligram strength, in 200-count, 500-count, and 1,000-count bottles. No other strengths of the over-the-counter pain reliever were included in the recall.

The medication was recalled by India-based Aurobindo Pharma USA Inc., according to the FDA notices. The medication was manufactured in India.

While the recalls were initiated on Sept. 18, the three reports were not published on the FDA’s recall database until this past week. The FDA also has not yet classified the action.

The reason for the recall is “discoloration: consumer complaints received for discolored tablets,” according to the notices. No other details were provided.

Acetaminophen, which is commonly sold under the brand name Tylenol, is among the most common pain relievers in U.S. homes. Tylenol products were not impacted in the current recall.

Last year, Aurobindo Pharma recalled 4,608 bottles of Amazon-sold acetaminophen in 325-milligram strength, with the FDA saying at the time that it was due to discoloration.

The report said the reason was for “cGMP deviations: Due to confirmed consumer complaints received with the observation of tablet discoloration (brown surface on tablets).”

The FDA designated the earlier recall as Class II, when there is “a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”

The FDA issued at least two warning letters to Aurobindo Pharma in 2019 and 2022 due to “significant deviations from current good manufacturing practice” following agency inspections of two company factories in India.

Products Under Recall

The products that were impacted under the recall are acetaminophen caplets in 500-milligram strength, distributed by Amazon.com Services LLC:

The FDA did not issue any guidance on what consumers should do if they have the recalled products. The recall notices can be found on the agency’s recall database.