Recalls / Class II
Class IID-0471-2025
Product
Acetaminophen Tablets, 325 mg, 100-count bottles, Distributed by: Amazon.com Services LLC, 410 Terry Avenue N., Seattle, WA 98109, NDC 72288-405-10
- Brand name
- Amazon Basic Care Acetaminophen
- Generic name
- Acetaminophen
- Active ingredient
- Acetaminophen
- Route
- Oral
- NDC
- 72288-405
- FDA application
- M013
- Affected lot / code info
- Lot#: AEF124004A, Exp date 08/31/2026
Why it was recalled
cGMP deviations: Due to confirmed consumer complaints received with the observation of tablet discoloration (brown surface on tablets).
Recalling firm
- Firm
- Aurobindo Pharma USA Inc
- Manufacturer
- Amazon.com Services LLC
- Notification channel
- Type
- Voluntary: Firm initiated
- Address
- 279 Princeton Hightstown Rd, N/A, East Windsor, New Jersey 08520-1401
Distribution
- Quantity
- 4,608 bottles
- Distribution pattern
- USA Nationwide.
Timeline
- Recall initiated
- 2025-05-22
- FDA classified
- 2025-06-17
- Posted by FDA
- 2025-06-25
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0471-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.