FDA Drug Recalls

Recalls / Class III

Class IIID-0195-2025

Product

Acetaminophen, 325 mg Tablets, 100 Tablets per bottle, Akron Pharma, Manufactured for: Akron Pharma Inc., Fairfield, NJ 07034, NDC 71399-8014-01.

Affected lot / code info
Lot #s: KDT0124004, KDT0124005, KDT0124006, Exp 08/31/2026

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
14825 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-0195-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.