FDA Drug recall D-0198-2025
Diphenhydramine HCl 25 mg, 1000 Capsules per bottle, Akron Pharma, Manufactured for: Akron Pharma, Inc., 373 RT US 46 W Building E., Suite…
- FDA Drug
- Class III
- ongoing
- Published 2025-01-22
On 2025-01-22 the FDA classified a Class III recall of Diphenhydramine HCl 25 mg, 1000 Capsules per bottle, Akron Pharma, Manufactured for: Akron Pharma, Inc., 373 RT US 46 W Building E., Suite… by Akron Pharma, citing labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0198-2025 |
| Classification | Class III |
| Status | ongoing |
| Initiated | 2024-12-12 |
| Published | 2025-01-22 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Akron Pharma |
| Distribution | US |
Product
Diphenhydramine HCl 25 mg, 1000 Capsules per bottle, Akron Pharma, Manufactured for: Akron Pharma, Inc., 373 RT US 46 W Building E., Suite 117, Fairfield, NJ 07004, NDC 71399-8028-2.
Reason
Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
Identifiers
| code_info | Lot: KDC0124002B Exp 09/30/2026 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0198-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.