WASHINGTON (WKRC) — More than 112,000 bottles of Amazon-brand acetaminophen are being recalled nationwide after consumers reported discolored tablets, according to the Food and Drug Administration.
Aurobindo Pharma USA initiated the voluntary recall Sept. 18 for 112,932 bottles of 500-milligram acetaminophen caplets. The products were sold in 200-count, 500-count and 1,000-count bottles and distributed by Amazon.com Services LLC.
The medication was made in India. The recall does not include other acetaminophen strengths or Tylenol-branded products.
The FDA notices cite complaints involving discolored tablets but do not provide additional details.
The largest portion of the recall involves 90,456 bottles containing 500 caplets. Those products carry NDC 72288-692-50 and UPC 1 95515 04890 3. The affected lots are:
ACD124036A and ACD124030A, expiring Sept. 30, 2027ACD124042A, expiring Oct. 31, 2027ACD124048B, expiring Nov. 30, 2027ACD125010A, expiring Feb. 29, 2028
The recall also includes 14,640 200-count bottles, NDC 72288-692-20, UPC 1 95515 04887 3, from lot ACD125040A with an expiration date of Sept. 30, 2027.
An additional 7,836 1,000-count bottles are affected. They are marked NDC 72288-692-01, UPC 1 95515 04888 0, lot ACD124048A, with an expiration date of Nov. 30, 2027.
Consumers should compare the NDC, UPC, lot number and expiration date on their bottle with the FDA’s recall listing. People with questions about using a recalled medication should speak with a pharmacist or health care provider.
Aurobindo recalled 4,608 bottles of a different Amazon acetaminophen product last year because of discoloration. The FDA classified that earlier action as a Class II recall, meaning use of the product could cause temporary or medically reversible health effects, while the risk of serious consequences was considered remote.
The latest recall remains ongoing and has not yet been classified by the FDA.