It’s often referred to as Tylenol, but thousands of over-the-counter drugs are being recalled after customers noticed something strange.
More Than 4,600 Bottles of a Pain Reliever Have Been Recalled Nationwide
Published on Jun. 20, 2025
All year, we wait for the return of summer when we can once again don our bikinis and lounge by the pool. But the hottest season also signals weeks packed with children’s pool parties, playdates, and activities to keep little ones entertained. And these things are…loud.
So, you’ll want to keep a bottle of over-the-counter painkillers like acetaminophen nearby for inevitable headaches. But a new drug recall may prompt you to replace the bottle in your medicine cabinet with a brand new one.
On Tuesday, the U.S. Food and Drug Administration (FDA) announced the recall of 4,608 bottles of acetaminophen tablets across the country due to “cGMP deviations.”
Current Good Manufacturing Practice (cGMP) regulations are meant to, in part, ensure that “a product is safe for use, and that it has the ingredients and strength it claims to have.”
The FDA report indicates that Aurobindo Pharma USA Inc, a company based in East Windsor, NJ, initiated the recall “due to confirmed consumer complaints received with the observation of tablet discoloration (brown surface on tablets).”
The FDA shared these details:
- Product: Acetaminophen Tablets, 325 mg, 100-count bottles
- Distributed by: Amazon.com Services LLC in Seattle, Washington
- National Drug Code (NDC): 72288-405-10
- Lot #: AEF124004A
- Expiration date: 08/31/2026
A press release from Aurobindo Pharma describes the product as “White to off white, round shaped uncoated tablets debossed with ‘N74’ on one side and plain on other side.” An image in the notice suggests that bottles were packaged in gray boxes with “Amazon” printed on its top left side.
It also states: “Amazon.com began shipping batch AEF124004A from 4/18/2025 to 5/8/2025.”
The FDA labeled the recall as a Class II risk, which signals that “use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences.”
Aurobindo Pharma says it has received five reports of “adverse events that are confirmed with this recall.”
Though the FDA alerted the public to the recall’s classification on June 17, the report indicates that Aurobindo Pharma initiated the recall on May 22.
Consumers can return the recalled product by completing and returning a Product Return Response Form. Details about the return process can be found in Aurobindo Pharma’s notice.
Consumers can contact PharmaLink—a “choice provider for pharmaceutical return and disposal solutions,” according to its website—with questions about the recall at (888) 256-1568.
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