Aurobindo Recalls 112,932 Bottles of Amazon-Brand Acetaminophen Over Discolored Tablets

More than 112,000 bottles of Amazon-brand pain reliever are under recall because customers found discolored pills.

Aurobindo Pharma USA Inc., based in New Jersey, started the voluntary recall on Sept. 18. The FDA posted it in its enforcement report on Oct. 2, two weeks later. The recall covers 112,932 bottles of Amazon Basic Care Extra Strength Acetaminophen 500 mg caplets, made in India and distributed by Amazon.com Services LLC.

The FDA's stated reason is one line: "Discoloration: consumer complaints received for discolored tablets." The tablets are supposed to be white to off-white. No other details were published.

Which bottles are affected

Three FDA entries cover three bottle sizes:

• 200-count: 14,640 bottles, NDC 72288-692-20, lot ACD125040A, expiring 09/30/2027.
• 500-count: 90,456 bottles, NDC 72288-692-50. Lots are ACD124036A and ACD124030A (expiring 09/30/2027), ACD124042A (10/31/2027), ACD124048B (11/30/2027) and ACD125010A (02/29/2028).
• 1,000-count: 7,836 bottles, NDC 72288-692-01, lot ACD124048A, expiring 11/30/2027.

The lot number and expiration date are printed on the bottle label. Other lots are not part of the recall. Distribution was nationwide. No other strengths are included, and Tylenol-brand products are not affected.

What the FDA and Amazon have said

The FDA lists the recall as "Not Yet Classified." That means the agency has not formally said how serious the problem is. Classification is the step that sets the health-risk level, from Class I (most serious) to Class III.

Amazon told Nexstar the recall was "initiated in coordination with the manufacturer, Aurohealth, and the FDA." The spokesperson said affected customers have likely already been contacted. No adverse events tied to the recalled acetaminophen have been reported.

That is the company's position. A change in a tablet's appearance does not by itself show the medicine is harmful. Still, color is one of the few quality problems a consumer can see.

The FDA's consumer guidance, as relayed in the notice, is for anyone with an affected product to contact a pharmacist or healthcare provider.

Not the first time

In May 2025, Aurobindo recalled 4,608 bottles of Amazon-distributed acetaminophen in 325 mg strength. The reason was tablet discoloration, described in FDA records as a "brown surface on tablets." The FDA cited "cGMP deviations," meaning current good manufacturing practice, the rules governing how drugs are made, tested and stored. It placed that recall in Class II, defined as a situation where exposure "may cause temporary or medically reversible adverse health consequences" or where the probability of serious harm is remote.

The new recall involves roughly 24 times as many bottles, though the bottle sizes differ. It does not yet carry a cGMP citation or a class. Neither Aurobindo nor the FDA has publicly said what caused the color change in the 500 mg lots.

The FDA also issued at least two warning letters to Aurobindo Pharma, in 2019 and 2022, citing "significant deviations from current good manufacturing practice" after inspections of two of the company's factories in India. Nothing published ties those letters to the current recall.

What remains open

Two things are unresolved. One is the FDA's classification, which will show how the agency rates the risk. The other is the cause. Whether the discoloration traces to a manufacturing deviation, as in 2025, or to something else has not been disclosed.

The 14-day gap between the Sept. 18 recall start and the Oct. 2 public posting is also on the record. Amazon has said customers with affected bottles were likely contacted directly. Anyone who bought a big bottle online and has not heard anything should check the lot number on the label against the list above.

Amazon and Aurobindo have not said how many of the 112,932 bottles were sold to customers versus still in inventory. The FDA's classification is the next public marker.