Recalls / Class III
Class IIID-0196-2025
Product
Acetaminophen Extra Strength 500 mg, 1000 Tablets per bottle, Akron Pharma, Manufactured for: Akron Pharma Inc., 373 US RT 46 W Building E, Suite 117, Fairfield, NJ 07034, NDC 71399-8022-02
- Affected lot / code info
- Lot #s: KDT0224001B, Exp 08/31/2026; KDT0224002B, Exp 09/30/2026.
Why it was recalled
Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
Recalling firm
- Firm
- Akron Pharma, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 373 Us Highway 46 Ste 117, Fairfield, New Jersey 07004-2456
Distribution
- Quantity
- 1232 bottles
- Distribution pattern
- Nationwide in the US
Timeline
- Recall initiated
- 2024-12-12
- FDA classified
- 2025-01-10
- Posted by FDA
- 2025-01-22
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0196-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.