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More than 112,000 bottles of Amazon brand extra-strength acetaminophen have been recalled after consumers reported discolored pills, according to the Food and Drug Administration (FDA).
Aurobindo Pharma USA, a New Jersey-based pharmaceutical company, initiated the voluntary recall on September 18, affecting three bottle sizes of Amazon’s 500 mg extra strength acetaminophen caplets.
The recall is still ongoing, according to the FDA.
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More than 112,000 bottles of Amazon brand Extra Strength Acetaminophen 500 mg caplets are being recalled following consumer complaints about discolored tablets, according to the FDA. (Douglas Rissing/Getty Images / Getty Images)
The recall covers 14,640 vials containing 200 caplets, 90,456 vials containing 500 caplets and 7,836 vials containing 1,000 caplets.
The FDA said the recall was prompted by consumer complaints about discolored tablets.
Information provided by the FDA does not identify the cause of the discoloration.
Amazon confirmed the voluntary recall, saying it was working with the manufacturer and federal regulators.
“Amazon is voluntarily recalling specific lots of Amazon Basic Care Extra Strength Acetaminophen 500 mg Pain Relief Caplets due to reports of discoloration of the tablets in affected lots,” an Amazon spokesperson told FOX Business.
“This is a voluntary recall initiated in coordination with the manufacturer, Aurohealth and the FDA.”
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The Food and Drug Administration has listed an ongoing voluntary recall of Amazon brand acetaminophen involving more than 112,000 bottles. (Sarah Silbiger/Getty Images/Getty Images)
The agency also did not describe any specific health risks or indicate whether any injuries had been reported in connection with the recall.
Affected lot numbers for 200-unit bottles are ACD125040A; for 500 unit bottles, ACD124036A, ACD124030A, ACD124042A, ACD124048B and ACD125010A; and for 1,000 count bottles, ACD124048A.
The affected products were manufactured in India and distributed by Amazon.com Services LLC, based in Seattle, Washington.
The recall follows a separate voluntary recall launched on September 3 by Indian company Inventia Healthcare Ltd. involving 13,567 bottles of 25-milligram chlorthalidone tablets that did not meet dissolution specifications, according to the FDA.
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Amazon brand acetaminophen distributed by Amazon.com Services LLC is subject to a voluntary recall affecting 112,932 bottles in three package sizes. (Photographer: Bridget Bennett/Bloomberg via Getty Images / Getty Images)
FOX Business has contacted Aurohealth for comment.
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