Nearly 113,000 Bottles of Acetaminophen Sold on Amazon Recalled Over Discoloration Reports

Thousands of Bottles of Acetaminophen Recalled from Amazon

Nearly 113,000 bottles of 500-milligram extra strength acetaminophen caplets sold on Amazon have been recalled following reports of tablet discoloration. The United States Food and Drug Administration (FDA) issued a recall notice in its recent enforcement report, highlighting potential concerns with several specific lots of over the counter medication.

Details of the Acetaminophen Recall

The recall was initiated last month but was recently included in the FDA’s official records. It affects Amazon Basic Care Extra Strength Pain Relief acetaminophen 500mg caplets, which were available through Amazon.com. The affected products, manufactured by Aurohealth, have been linked to multiple reports of discolored acetaminophen tablets.

According to the FDA’s alerts, the recall includes:

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

The complete lists of affected lot numbers are available through the FDA’s recall database.

Reason for the Recall: Tablet Discoloration

Customers first reported the discoloration of the acetaminophen tablets, prompting this voluntary recall. In a statement provided to Nexstar, an Amazon spokesperson confirmed: “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.” The recall was coordinated with manufacturer Aurohealth and the FDA.

So far, according to the recall notice, there have been no reports of adverse effects tied to the affected acetaminophen bottles. Customers with potentially impacted bottles have likely already received notifications from Amazon or the manufacturer.

Past Acetaminophen Recalls and Manufacturer Action

This event is not the first acetaminophen recall involving Aurohealth or its parent, Aurobindo. Last year, Aurobindo issued a similar recall for 325-milligram acetaminophen tablets sold on Amazon after customers noticed a “brown surface on tablets.” In 2022, Aurohealth recalled more than 160,000 bottles due to packaging issues affecting child-resistant safety. These included approximately 137,300 bottles of Walgreens brand acetaminophen and about 25,660 bottles of Kroger brand arthritis pain acetaminophen.

Understanding Acetaminophen and Consumer Guidance

Acetaminophen, widely used as an over the counter medication, is classified as both an analgesic and antipyretic—helping to relieve pain and reduce fever. According to MedlinePlus, it works by altering the way the body senses pain and by cooling it down.

Consumers who possess bottles with the affected lot numbers are encouraged to discontinue use and follow recall instructions. At this time, no adverse health incidents have been identified related to this medication recall in 2026. For concerns relating to acetaminophen safety, individuals should consult healthcare professionals or the FDA recall database for more information.

Further Information and Ongoing Updates

The FDA continues to monitor over the counter medication recalls and provides updates on its enforcement report page. For questions about specific products involved in the acetaminophen recall, customers can contact Amazon, Aurohealth, or refer to the FDA recall reports.

Source: whnt.com.