More than 112,000 bottles of acetaminophen pain reliever sold on Amazon recalled over quality concerns
More than 112,000 bottles of pain relievers sold on Amazon have been recalled over quality concerns.
India-based Aurobindo Pharma USA Inc has pulled 112,932 bottles of its generic acetaminophen nationwide after they received complaints from consumers who said the tablets were ‘discolored.’
The recalled tablets contained 500 milligrams of acetaminophen and had been sold in 200-, 500-, and 1,000-count bottles. They have best-by dates up to February 2028.
The product was first recalled on September 18, but was not listed in the Food and Drug Administration’s (FDA) recall database until Monday.
There have been no reports of illnesses in relation to this recall.
The FDA has not assigned a risk level to this recall.
No advice has been issued, but in previous cases, consumers were told not to consume recalled acetaminophen and to return it to the place of purchase for a full refund.
The recall included a total of 90,456 500-count bottles of acetaminophen, which have the lot codes, found near the barcode, of ACD124036A, ACD124030A, ACD124042A, ACD124048b and ACD125010A.
More than 113,000 bottles of pain relievers sold through Amazon were recalled over quality concerns
Their expiration dates varied from September 2027 to February 2028.
A total of 14,640 200-count bottles were also included in the recall. These had the lot code ACD125040A and the best-by date of September 2027.
A further 7,836 1,000-count bottles were also included, which had the lot code ACD124048A and the best-by date of November next year.
No additional details about the discoloration or the underlying issue with the medication were provided.
Discoloration can be a sign that a medication has degraded or otherwise changed from its intended formulation.
It can be caused by moisture, heat, chemical degradation or manufacturing problems.
Abnormal coloration of medications suggests they may no longer meet required standards.
The recall notice did not specify what caused the tablets to become discolored.
It is not the first instance that Aurobindo Pharma recalled acetaminophen pills due to discoloration.
In 2025, the pharmaceutical giant recalled 4,608 bottles of its generic acetaminophen tablets sold through Amazon, also after it received complaints of tablet discoloration, specifically a ‘brown surface on tablets.’
This previous recall was classified as Class II, indicating ‘a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.’
Aurobindo Pharma previously faced scrutiny from the FDA over its manufacturing practices.
In 2019 and 2022, the FDA issued warning letters to Aurobindo Pharma citing ‘significant deviations from current good manufacturing practice’ after inspecting two of the company’s factories in India.
Acetaminophen is one of the most common medications in the US, with around one in five, or 20 percent, of American adults estimated to take an acetaminophen-containing medicine in any given week.
The pain reliever is used to reduce fever and treat a wide variety of everyday ailments, such as headaches, muscle pain, back pain, and menstrual cramps.
