The voluntary recall covers seven lots of 500-milligram caplets after consumers reported discoloration in some of the tablets.
WASHINGTON — More than 112,000 bottles of Amazon-branded Extra Strength Acetaminophen are being recalled nationwide after consumers reported discolored tablets, according to federal recall information and the company involved.
Aurobindo Pharma USA Inc. initiated the voluntary recall Sept. 18, affecting 112,932 bottles of extra-strength 500-milligram acetaminophen distributed by Amazon.com Services LLC. The recall covers specific lots packaged in bottles containing 200, 500 or 1,000 caplets. Federal information lists the reason for the action as consumer complaints involving tablet discoloration.
The largest share involves 90,456 bottles containing 500 caplets. Another 14,640 recalled bottles contain 200 caplets, while 7,836 contain 1,000 caplets. The affected medication was manufactured in India and distributed nationwide through Amazon. The recall does not cover all acetaminophen products sold by Amazon or products sold under the Tylenol brand.
The affected 200-count bottles carry lot number ACD125040A. Recalled 500-count bottles have lot numbers ACD124036A, ACD124030A, ACD124042A, ACD124048B or ACD125010A. The affected 1,000-count bottles carry lot number ACD124048A. The corresponding National Drug Code numbers are 72288-692-20 for the 200-count bottles, 72288-692-50 for the 500-count bottles and 72288-692-01 for the 1,000-count bottles.
The Food and Drug Administration had not assigned the recall a Class I, Class II or Class III health-risk classification in the available enforcement information. An unclassified recall does not by itself indicate how serious a risk a product presents because FDA classifications can be assigned after a company has already begun removing a product from distribution.
Amazon said the voluntary action was being conducted with the manufacturer and the FDA. The company said it has contacted customers identified as having purchased affected medication and is providing refunds after customers confirm disposal of the recalled product. Buyers can use the lot number printed on their bottle to determine whether their medication is among the specific products covered.
No adverse health events have been reported in connection with the affected tablets, according to information provided by Amazon and reported by People. A Health Hazard Evaluation also found that the reported discoloration did not affect the medication’s safety or effectiveness. The publicly available recall information has not identified what caused the tablets to become discolored.
Acetaminophen is a widely used over-the-counter medication for pain and fever. Although Tylenol contains acetaminophen, this recall concerns specific Amazon-branded generic 500-milligram caplets manufactured by Aurobindo Pharma USA and does not represent a nationwide recall of Tylenol or every generic acetaminophen product.
The recall remained ongoing in the latest available federal and company information. Customers who purchased Amazon Basic Care Extra Strength Pain Relief can compare the lot number and bottle size on their package with the affected products identified in the recall notice.
Author note: Last updated October 14, 2026.