FDA Recall D-0197-2025
Akron Pharma, Inc. · Fairfield, NJ
Class III Ongoing 518 days on record
Lower impact — Class III recall — product violates FDA labeling or manufacturing standards but is unlikely to cause adverse health consequences.
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.
Reason for recall
Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
Recall record
- Recall number
D-0197-2025- Classification
- Class III
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Nationwide in the US
- Recall initiated
- 2024-12-12
- Classified by FDA Center
- 2025-01-10
- FDA published
- 2025-01-22
- Recalling firm
- Akron Pharma, Inc.
- Firm location
- Fairfield, NJ
Operational response
Class III recalls are unlikely to cause adverse health consequences but indicate a violation of FDA labeling or manufacturing standards. Pull from active dispensing per your operational policy.
For the official FDA enforcement record, see FDA's Recall Search.