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Acetaminophen Sold on Amazon Recalled over Complaints
The FDA has not yet assigned a risk class, and officials have not said what caused the tablet discoloration.
- Amazon.com Services LLC recalled 112,932 bottles of 500 mg acetaminophen caplets on September 18, 2026, after consumers reported discolored tablets in the pain reliever distributed through the online retailer.
- Aurobindo initiated the recall following consumer complaints of discoloration; tablets should be white or off-white, but Food and Drug Administration officials have not confirmed whether degradation, contamination, or manufacturing issues caused the color change.
- Impacted items include 90,456 of the 500-count bottles, 14,640 of the 200-count bottles, and 7,836 of the 1,000-count bottles with specific lot numbers ACD125040A and ACD124048A. Consumers can verify affected products by checking labels against the official recall list.
- Consumers holding affected bottles should stop using the product and contact Amazon for returns or refunds while seeking pharmacist guidance for replacements. The FDA has not yet classified the recall's risk level as of the October 2 report.
- This marks a second discoloration-related recall for Aurobindo products sold by Amazon, following a 2025 recall of 4,608 bottles. The FDA previously issued warning letters to Aurobindo in 2019 and 2022 regarding 'significant deviations from current good manufacturing practice.
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Indian Company Recalls 113,000 Bottles of Acetaminophen Sold Through Amazon
More than 100,000 bottles of generic acetaminophen sold through Amazon were recalled by an India-based manufacturer due to consumer complaints about discoloration, according to notices published on the Food and Drug Administration’s website this past week. The recall impacts Amazon acetaminophen caplets in 500-milligram strength, in 200-count, 500-count, and 1,000-count bottles. No other strengths of the over-the-counter pain reliever were inclu…
·New York, United States
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