Aurobindo Pharma USA has initiated a nationwide recall of Amazon-branded Extra Strength Acetaminophen, 500 milligrams, after consumer complaints of discolored tablets.
The voluntary, firm-initiated recall began Sept. 18 and remains ongoing, according to an FDA enforcement report. The products were distributed by Amazon.com Services and made in India.
The recall covers three product entries: 14,640 200-count bottles, 90,456 500-count bottles and 7,836 1,000-count bottles. The FDA listed discoloration and consumer complaints of discolored tablets as the reason for each recall.
The FDA has not yet classified the recall. No news release was issued for the recall.
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