FDA Drug recall D-0226-2025
Lorazepam Tablets, USP, 0.5mg, Unit Dose, 100 tablets per carton (10 x 10 blister packs), Rx only, The drug product contained in this packa…
- FDA Drug
- Class II
- ongoing
- Published 2025-02-26
On 2025-02-26 the FDA classified a Class II recall of Lorazepam Tablets, USP, 0.5mg, Unit Dose, 100 tablets per carton (10 x 10 blister packs), Rx only, The drug product contained in this packa… by The Harvard Drug Group, citing failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results were obtained during routine stability testing for Assay and Impurities.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0226-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-01-21 |
| Published | 2025-02-26 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | The Harvard Drug Group |
| Distribution | US |
Product
Lorazepam Tablets, USP, 0.5mg, Unit Dose, 100 tablets per carton (10 x 10 blister packs), Rx only, The drug product contained in this package is from NDC # 69315-904 Leading Pharma, LLC., Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 26268 USA, NDC: 0904-6007-61
Reason
Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results were obtained during routine stability testing for Assay and Impurities.
Identifiers
| code_info | Lot #s: N01424, N01425, Exp 03/31/2025; N01659, N01660, Exp 08/31/2025; N01668, 09/2025; N01679, N01704, N01745, Exp 10…Lot #s: N01424, N01425, Exp 03/31/2025; N01659, N01660, Exp 08/31/2025; N01668, 09/2025; N01679, N01704, N01745, Exp 10/31/2025; N01856, Exp 02/28/2026; N01973, Exp 05/31/2026; N02079, Exp 08/31/2026. |
|---|
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-0226-2025%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.