Thousands of acetaminophen bottles sold on Amazon recalled over discoloration

Federal regulators posted notice that thousands of pain relief bottles sold nationwide face an active recall. The action covers nearly 113,000 bottles of 500-milligram Extra Strength Acetaminophen caplets. Customers reported discolored pills inside the affected packages, according to the U.S. Food and Drug Administration.

The voluntary recalls began last month. The agency only recently included the actions in its enforcement report.

Three separate alerts on the agency site list the affected items:

• 14,640 200-count bottles with lot number ACD125040A and an expiration date of 09/30/2027
• 90,456 500-count bottles with multiple lot numbers and expiration dates: ACD124036A and ACD124030A expiring 09/30/2027; ACD124042A expiring 10/31/2027; ACD124048B expiring 11/30/2027; ACD125010A expiring 02/29/2028
• 7,836 1,000-count bottles with lot number ACD124048A and expiration date 11/30/2027

An Amazon spokesperson addressed the decision in a statement.

Amazon is voluntarily recalling specific lots of Amazon Basic Care Extra Strength Pain Relief acetaminophen 500mg caplets due to reports of tablet discoloration in the affected lots. This is a voluntary recall initiated in coordination with the manufacturer, Aurohealth, and the FDA.

Customers with an impacted bottle likely received contact already. There have been no reported adverse impacts from the affected pills.

Last year, Aurobindo issued a similar recall for 325-milligram Acetaminophen Tablets sold online. That action followed consumer reports of a “brown surface on tablets,” according to a company notice.

In 2022, the company recalled more than 160,000 bottles over child-resistant packaging issues. That total included about 137,300 Walgreens units and roughly 25,660 Kroger units.

The Food and Drug Administration monitors product recalls across the country. Companies pull products when items fail quality standards. Agency notices inform the public about potential batch defects.

Acetaminophen relieves pain and reduces fevers, MedlinePlus explains. It cools the body.