Reports about discolored tablets have prompted the recall of more than 112,000 bottles of Amazon-branded extra-strength acetaminophen, according to a notice posted by the U.S. Food & Drug Administration.
The voluntary recall was initiated on Sept. 18 by New Jersey-based Aurobindo Pharma USA Inc., according to the notice. Three bottle sizes of Amazon Extra Strength Acetaminophen 500-milligram caplets, totaling 112,932 bottles, are being recalled, Fox News reported.
According to the notice, 14,640 200-count bottles were recalled, along with 90,456 500-count bottles and 7,836 1000-count bottles.
More than 112,000 bottles of the medication is being recalled, according to the U.S. Food and Drug Administration. https://t.co/uI2SPzWeeh
— USA TODAY (@USATODAY) October 12, 2026
Acetaminophen is a common over-the-counter medication used by consumers to relieve pain and reduce fever, USA Today reported, citing Drugs.com.
So far, the FDA has not yet assigned a classification that would indicate the level of health risks associated with the recall, according to the newspaper.
The lot numbers are ACD125040A (200-count bottles); ACD124036A, ACD124030A, ACD124042A, ACD124048B and ACD125010A (500-count bottles); and ACD124048A (1,000-count bottles).
The recalled items were manufactured in India and distributed by Amazon.com Services LLC, based in Seattle, according to the notice.
It was unclear what caused the discoloration of the caplets.
Officials at Amazon told Fox News that it was working with the product’s manufacturer and federal regulators.
In a statement to USA Today, Amazon said the recall was done in “coordination with the manufacturer, Aurohealth, and the FDA.”
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