Lorazepam Tablets — Class II drug recall D-0226-2025
Ongoing recall by The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories, reported 2025-02-26, distributed nationwide. Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results were obtained d
| Recall number | D-0226-2025 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories, La Vergne, TN, United States |
| Recall initiated | 2025-01-21 |
| Classified | 2025-02-19 |
| Reported by FDA | 2025-02-26 |
| Distributed | Nationwide (US) |
| Quantity | 82,281 cartons |
| Reason classes | potency, specification failure |
| NDC | 00904-6007-61 |
| Lot numbers | N01424, N01425, N01659, N01660, N01668, N01679, N01704, N01745, N01856, N01973, N02079 |
| Expiration dates | 2025-03-31, 2025-08-31, 2025-10-31, 2026-02-28, 2026-05-31, 2026-08-31 |
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 for recall
Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results were obtained during routine stability testing for Assay and Impurities.
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-0226-2025. 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.