Recalls / Class III
Class IIID-0197-2025
Product
Diphenhydramine HCl 25 mg, 100 capsules per bottle, Akron Pharma, Manufactured for: Akron Pharma, Inc., 373 RT US 46 W Building E, Suite 117, Fairfield, NJ 07004, NDC 71399-8028-1.
- Affected lot / code info
- Lot: KDC0124001A 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
- 7198 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-0197-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.