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Amazon Recalls Over 112,000 Bottles of Acetaminophen Over Discolored Pills

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Skeletal formula of paracetamol (N-(4-hydroxyphenyl)ethanamide, C 8 H 9 NO 2 ).
Image credit: Benjah-bmm27 · Public domain · Wikimedia Commons

In brief

Aurobindo Pharma USA has voluntarily recalled 112,932 bottles of Amazon Basic Care Extra Strength Acetaminophen sold nationwide through Amazon after customers reported discolored caplets. The recall, covering seven lot numbers across 200-, 500- and 1,000-count bottles, began September 18, 2026, and the FDA has not yet assigned it a risk classification.

What is being recalled

Aurobindo Pharma USA Inc. has recalled 112,932 bottles of 500-milligram Amazon Basic Care Extra Strength Acetaminophen caplets sold nationwide through Amazon, according to Hoodline and Local 12, both of which cite the manufacturer's recall notice. The caplets were manufactured in India by Aurobindo Pharma Limited and distributed by Amazon.com Services LLC, Local 12 reported.

The recall covers three bottle sizes: 90,456 bottles of 500-count packs, 14,640 bottles of 200-count packs, and 7,836 bottles of 1,000-count packs, per figures reported by Hoodline.

Why the recall was issued

Aurobindo initiated the voluntary recall on September 18, 2026, after receiving consumer complaints about discolored tablets, Hoodline and Local 12 reported. Neither outlet described injuries linked to the discoloration, and medical health-news site MedShadow Foundation likewise reported no injuries associated with the recall as of its report.

Recalled lot numbers by bottle size
Bottle sizeLot number(s)Expiration date
200-countACD125040A09/30/2027
500-countACD124036A, ACD124030A09/30/2027
500-countACD124042A10/31/2027
500-countACD124048B11/30/2027
500-countACD125010A02/29/2028
1,000-countACD124048A11/30/2027

FDA status and a prior recall

As of the reports from Hoodline and Local 12, the Food and Drug Administration had not yet assigned a risk classification to the recall. Hoodline reported that a separate, earlier recall of 4,608 bottles of Amazon's 325-milligram acetaminophen in 2025, triggered by reports of a 'brown surface' on tablets, was later classified by the FDA as Class II, a category the agency uses when a product may cause temporary or reversible health effects. Local 12 also reported that 4,608 bottles were recalled in 2025 over discoloration, without using that specific wording.

What consumers should do

Questions

What product is affected by the recall?
Amazon Basic Care Extra Strength Acetaminophen, 500-milligram caplets sold in 200-count, 500-count and 1,000-count bottles through Amazon, according to Hoodline and Local 12.
How many bottles were recalled?
112,932 bottles in total: 90,456 of the 500-count size, 14,640 of the 200-count size, and 7,836 of the 1,000-count size, per Hoodline's report.
Why was the acetaminophen recalled?
Aurobindo Pharma USA recalled the product after consumers reported discolored tablets, according to Hoodline, Local 12 and MedShadow Foundation. None of the reports described confirmed injuries.
Has the FDA classified the health risk?
As of the available reports, the FDA had not yet assigned a risk classification to this recall, though a similar 2025 Amazon acetaminophen recall was later classified Class II, Hoodline reported.
Has Amazon-brand acetaminophen been recalled before?
Yes. Hoodline and Local 12 reported that Aurobindo recalled 4,608 bottles of Amazon's 325-milligram acetaminophen in 2025 after consumers reported discoloration, which Hoodline described as a 'brown surface' on the tablets.

Sources

  1. Hoodline — Amazon Acetaminophen Recall: 112,932 Bottles Pulled Nationwide
  2. Local 12 — Acetaminophen recall affects more than 112,000 bottles nationwide after complaints
  3. MedShadow Foundation — FDA Recalls and Warnings: Amazon Acetaminophen, Millions of Eye Drops and More Compounded Glutathione

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