Diphenhydramine HCl 25 mg — Class III drug recall D-0197-2025
Ongoing recall by Akron Pharma, Inc., reported 2025-01-22, distributed nationwide. Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
| Recall number | D-0197-2025 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Akron Pharma, Inc., Fairfield, NJ, United States |
| Recall initiated | 2024-12-12 |
| Classified | 2025-01-10 |
| Reported by FDA | 2025-01-22 |
| Distributed | Nationwide (US) |
| Quantity | 7,198 bottles |
| Reason classes | labeling |
| NDC | 71399-8028-01 |
| Lot numbers | KDC0124001A |
| Expiration dates | 2026-09-30 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0197-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.