FDA Drug recall D-0183-2025
Methadone Hydrochloride Tablets, USP, 5mg, 10x10 Unit-Dose Tablets, Rx Only, Distributed by: Hikma Pharmaceuticals USA Inc., Berkeley Heigh…
- FDA Drug
- Class III
- ongoing
- Published 2025-01-15
On 2025-01-15 the FDA classified a Class III recall of Methadone Hydrochloride Tablets, USP, 5mg, 10x10 Unit-Dose Tablets, Rx Only, Distributed by: Hikma Pharmaceuticals USA Inc., Berkeley Heigh… by West Ward Columbus, citing failed Tablet/Capsule Specifications: Illegible product identification for the unit dose configuration only.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0183-2025 |
| Classification | Class III |
| Status | ongoing |
| Initiated | 2024-12-19 |
| Published | 2025-01-15 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | West Ward Columbus |
| Distribution | US |
Product
Methadone Hydrochloride Tablets, USP, 5mg, 10x10 Unit-Dose Tablets, Rx Only, Distributed by: Hikma Pharmaceuticals USA Inc., Berkeley Heights, NJ 07922, NDC 0054-0709-20
Reason
Failed Tablet/Capsule Specifications: Illegible product identification for the unit dose configuration only.
Identifiers
| ndc | 0054-0709-25 |
|---|---|
| ndc | 0054-0709-20 |
| ndc | 0054-0710-25 |
| ndc | 0054-0710-20 |
| code_info | Lot # AC2556A; Exp. 03/2027 |
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-0183-2025%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.