FDA Class II Recall Issued for Acetaminophen Tablets Distributed by Amazon
Aurobindo Pharma USA Inc has voluntarily initiated a Class II recall of Acetaminophen Tablets, 325 mg, packaged in 100-count bottles and distributed under the Amazon.com Services LLC label (NDC 72288-405-10). The recall affects 4608 bottles from lot number AEF124004A, with an expiration date of August 31, 2026. This nationwide recall was initiated on May 22, 2025, following confirmed consumer complaints regarding tablet discoloration, specifically a brown surface observed on some tablets. The issue represents a deviation from current good manufacturing practices (cGMP), prompting the action despite no immediate health hazard being identified.
The US Food and Drug Administration classified the recall as Class II on June 17, 2025, indicating that use of the product may cause temporary or medically reversible adverse health consequences, but the probability of serious health effects is remote. The recall remains ongoing, and while no press release has been issued, initial notifications were made to consignees via email. The tablets were distributed throughout the US.
Acetaminophen is widely used as an over-the-counter analgesic and antipyretic, indicated for the temporary relief of minor aches and pains such as headaches, muscle aches, backaches, and fevers. It is critical for pharmacists to ensure inventory compliance with recall advisories, remove affected stock immediately, and counsel patients accordingly to prevent any potential quality-related risks.
