Aurobindo Pharma Recalls 1.12 Lakh Bottles of Amazon-Brand Paracetamol in US
New Delhi: Aurobindo Pharma USA Inc. is voluntarily recalling 1,12,932 bottles of Amazon-brand Extra Strength Acetaminophen 500 mg caplets in the United States following consumer complaints about discoloured tablets, according to the US Food and Drug Administration (USFDA) Enforcement Report.
The recall covers three pack sizes of the over-the-counter medication, comprising 90,456 bottles of 500-count packs, 7,836 bottles of 1,000-count packs and 14,640 bottles of 200-count packs. The recall actions were initiated on September 18, 2026, following complaints regarding tablet discolouration.
According to the FDA Enforcement Report, the affected products are listed as Amazon Extra Strength Acetaminophen 500 mg caplets. The products were manufactured in India by Aurobindo Pharma USA Inc. and distributed by Amazon.com Services LLC, located at 410 Terry Avenue North, Seattle, Washington.
The report identifies the 200-count pack under National Drug Code (NDC) 72288-692-20, with UPC 195515048873. The affected lot listed is ACD125040A, with an expiry date of September 30, 2027.
The 500-count pack is listed under NDC 72288-692-50, with UPC 195515048903. The Enforcement Report identifies multiple affected lots, including ACD124036A, ACD124030A, ACD124048B and ACD125010A, with expiry dates extending from September 2027 to February 2028.
The 1,000-count pack is listed under NDC 72288-692-01, with UPC 195515048880. The report identifies lot ACD124048A, with an expiry date of November 30, 2027.
The reason for the recall is recorded as consumer complaints regarding discoloured tablets. The FDA has listed all three recall entries under the drug category, with their classification status marked as “Not Yet Classified.”
Acetaminophen, commonly known as paracetamol, is widely used to relieve mild-to-moderate pain and reduce fever associated with colds, flu and other infections. The medicine is also used as an ingredient in more than 600 different drug formulations.
The recalling firm, Aurobindo Pharma USA Inc., is based at 279 Princeton Hightstown Road, East Windsor, New Jersey. The affected products were distributed by Amazon.com Services LLC under the Amazon brand, reports Economic Times Pharma.
Tylenol, marketed by Kenvue, the consumer healthcare company spun off from Johnson & Johnson, is among the most widely recognised acetaminophen brands in the United States and ranks among the country's top-selling medicines by volume.
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