Popular Amazon OTC medicine recalled nationwide, again
Although I used to buy over-the-counter (OTC) medicine from CVS or my local grocery store, I now buy anything I might take from Amazon. That’s because I’m ordering from the online giant nearly every day, and it’s rare that I need a painkiller, allergy relief pill, or something else to treat a minor ailment immediately.
Generally, if I notice that I’m running low on any OTC pills, I’ll add some to my current order and usually, that means buying Amazon’s house brand.
Amazon customers have now faced two recalls involving its house-brand acetaminophen.
“New Jersey-based Aurobindo Pharma USA Inc. initiated a nationwide recall of Amazon Basic Care Extra Strength Acetaminophen on Sept. 18, according to an Oct. 2 report published by the U.S. Food and Drug Administration (FDA).
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Here’s what the Amazon recall notice says
The recall was initiated by Aurobindo, which manufactured the drug. Under the reason for recall, the FDA shared the following: “Discoloration: consumer complaints received for discolored tablets.”
It also listed a variety of lots involved:
- Amazon, Acetaminophen, Extra Strength, 500mg Caplet, 200-count bottle, Distributed by: Amazon.com Services LLC, 410 Terry Avenue N., Seattle, WA 98109, Made in India, NDC 72288-692-20. UPC 1 95515 04887 3
- Amazon, Acetaminophen, Extra Strength, 500mg Caplets, 500-count bottle, Distributed by: Amazon.com Services LLC, 410 Terry Avenue N., Seattle, WA 98109, Made in India, NDC 72288-692-50. UPC 1 95515 04890 3
- Amazon, Acetaminophen, Extra Strength, 500mg Caplets, 1000-count bottle, Distributed by: Amazon.com Services LLC, 410 Terry Avenue N., Seattle, WA 98109, Made in India, NDC 72288-692-01. UPC 1 95515 04888 0
Across the three sizes, more than 112,000 bottles have been impacted.
The tablets should normally appear “white to off-white,” according to details from the National Library of Medicine.
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This isn’t the first Amazon acetaminophen recall
Amazon has been down this road before, and for the same reason.
“This isn’t the first recall of Amazon-brand acetaminophen over discoloration. In May 2025, Aurobindo Pharma USA recalled more than 4,000 bottles of Amazon Basic Care Acetaminophen after consumers reported “a brown surface” on some of the tablets. The FDA later classified that recall as Class II,” The Healthy reported.
The FDA classifies recalls based on the relative degree of health hazard, using three levels:
- Class I: The most serious recall. There is a reasonable probability that using or being exposed to the product could cause serious adverse health consequences or death.
- Class II: The product could cause temporary or medically reversible health consequences, or the chance of serious health consequences is considered remote.
- Class III: The product is not likely to cause adverse health consequences. These recalls generally involve the lowest health risk.
- Source: FDA
This Amazon case has not been classified.
What should Amazon customers do?
If you purchased these items from Amazon, you should have received a recall notice.
“Read the recall notice carefully and verify the product description such as brand name, packaging size, and codes such as expiration or best by dates to determine whether your product has been recalled. Be sure to follow any product-specific instructions. Additionally, contact the company for further information,” the FDA shared.
Amazon shared its recall policy on its website.
Following a product recall (Regulator or Manufacturer-driven) announcement, Amazon will:
- Suppress all product listings impacted by the recall.
- Cancel any existing orders and make the impacted inventory unsellable.
- Notify past customers of a publicly announced recall. Market withdrawals are handled on a case-by-case basis if policy or law requires messaging.
- Reinstate products after inventory removal and Letter of Compliance verification.
Amazon’s recall policy says its customer notifications include instructions for claiming a refund and what to do with the affected product.
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