Amazon brand acetaminophen recalled over discoloration, company says

Certain lots of Amazon-branded acetaminophen caplets have been recalled over discoloration that does not pose a health threat, the company said. 

A Food and Drug Administration Enforcement Report for the week of Oct. 7 showed three lots of 500mg Extra Strength Acetaminophen caplets, sold in 200-, 500- and 1,000-count bottles, were recalled on Sept. 18 due to "consumer complaints received for discolored tablets."

The drugs were recalled by Aurobindo Pharma USA Inc., and produced in India, the enforcement report shows. Acetaminophen is used for temporary fever and pain reduction. 

In a Sept. 30 recall letter the pharmaceutical company provided to Newsday, Aurobindo Pharma USA described the capsules as white to off-white and debossed with "N79" on one side. The company did not respond to request for clarification about whether this description applies to the recalled batches.

"Amazon is voluntarily recalling specific lots of Amazon Basic Care Extra Strength Pain Relief acetaminophen 500mg caplets due to reports of tablet discoloration in the affected lots," an Amazon spokesperson told Newsday in an emailed statement. "This is a voluntary recall initiated in coordination with the manufacturer, Aurohealth and the FDA."

Amazon said a Health Hazard Evaluation showed the discoloration did not affect the safety or efficacy of the drug, and that no adverse effects had been reported. Amazon said Wednesday that it had contacted customers who had purchased the recalled product and would issue refunds after confirming product disposal. 

The affected products have expiration dates of 9/30/27,10/31/27, 11/30/27 and 2/29/28, according to the enforcement report. 

By Arielle Dollinger

arielle.dollinger@newsday.com@aridollinger

Arielle Dollinger joined Newsday as a staff reporter in 2022. Previously, she covered local and national news as a freelancer for The New York Times, Newsday and other outlets.