The FDA reports that Aurobindo Pharma USA initiated a nationwide recall of Amazon Basic Care Extra Strength Acetaminophen after consumer complaints of discolored tablets. The recall affects three bottle sizes—200-, 500- and 1,000-count—with specific lot numbers and expiration dates listed by the agency, totaling 112,932 bottles. Consumers who purchased the product should check lot numbers, stop use if tablets appear discolored, and contact their pharmacist or healthcare provider for guidance. The action is currently listed as Not Yet Classified by the FDA; a related May 2025 recall was classified as Class II.
Over 112,900 Amazon-Brand Acetaminophen Bottles Recalled Nationwide After Reports of Discolored Tablets
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Acetaminophen, a widely used remedy for fever and pain, is sold under brand names such as Tylenol and as generics or store brands. If you buy over-the-counter medicines through Amazon, check your medicine cabinet: Aurobindo Pharma USA Inc. initiated a nationwide recall of Amazon Basic Care Extra Strength Acetaminophen on September 18, according to an October 2 report from the U.S. Food and Drug Administration (FDA).
The recall was prompted by consumer complaints that tablets are discolored. According to the National Library of Medicine, the product should normally appear "white to off-white." The current recall is listed as Not Yet Classified by the FDA.
Affected Products
The FDA lists three affected bottle sizes and the specific lot numbers and expiration dates below:
- Amazon Extra Strength Acetaminophen (500 mg), 200-count
Total Affected: 14,640 bottles
NDC: 72288-692-20
UPC: 1 95515 04887 3
Lot: ACD125040A
Expiration Date: 09/30/2027 - Amazon Extra Strength Acetaminophen (500 mg), 500-count
Total Affected: 90,456 bottles
NDC: 72288-692-50
UPC: 1 95515 04890 3
Lots: ACD124036A, ACD124030A (Exp. 09/30/2027); ACD124042A (Exp. 10/31/2027); ACD124048B (Exp. 11/30/2027); ACD125010A (Exp. 02/29/2028) - Amazon Extra Strength Acetaminophen (500 mg), 1000-count
Total Affected: 7,836 bottles
NDC: 72288-692-01
UPC: 1 95515 04888 0
Lot: ACD124048A
Expiration Date: 11/30/2027
Combined, these lots total 112,932 bottles recalled nationwide. The product is distributed by Amazon.com Services LLC and manufactured in India.
What Consumers Should Do
If you purchased any of the listed bottles, locate the lot number and expiration date on your container and compare it with the FDA list above. If your tablets appear discolored, have an unusual odor, or otherwise look different than normal, stop using the product and contact your pharmacist or healthcare provider for guidance. You may also follow FDA instructions on reporting complaints or adverse events.
Note: In May 2025, Aurobindo Pharma USA recalled more than 4,000 bottles of Amazon Basic Care acetaminophen for a "brown surface" on some tablets; that recall was later classified by the FDA as Class II.
For updates, consult the FDA recall notice and monitor communications from your pharmacy or retailer.
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