FDA Drug recall D-0227-2025
Lorazepam Tablets, USP, 1mg, Unit Dose, 100 tablets per carton (10 x 10 blister packs), Rx only, The drug product contained in this package…
- FDA Drug
- Class II
- ongoing
- Published 2025-02-26
On 2025-02-26 the FDA classified a Class II recall of Lorazepam Tablets, USP, 1mg, Unit Dose, 100 tablets per carton (10 x 10 blister packs), Rx only, The drug product contained in this package… 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-0227-2025 |
| 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, 1mg, Unit Dose, 100 tablets per carton (10 x 10 blister packs), Rx only, The drug product contained in this package is from NDC # 69315-905 Leading Pharma, LLC., Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 26268 USA, NDC: 0904-6008-61.
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: N01419, N01420, N01421, Exp 03/31/2025; N01663, Exp 06/30/2025; N01664, Exp 08/31/2025; N01673, Exp 09/30/2025;…Lot #s: N01419, N01420, N01421, Exp 03/31/2025; N01663, Exp 06/30/2025; N01664, Exp 08/31/2025; N01673, Exp 09/30/2025; N01688, Exp 08/31/2025; N01747, N01748, N01749, Exp 11/30/2025; N01792, Exp 12/31/2025; N01857, Exp 02/28/2026; N01974, Exp 05/31/2026; N02081, 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.
Other recalls by The Harvard Drug Group
- Carton Label: MAJOR, Methylergonovine Maleate Tablets, USP, 0.2 mg, 20 TABLETS (2 x 10), Rx only, Packaged and Distributed by: MAJOR PHARMA…
FDA Drug · Class II · 2026-07-01 · The Harvard Drug Group - Omega-3-Acid, Ethyl Esters, Capsules, USP, 1 gram, 50 capsules (5 x 10 unit dose blister cards) per carton, Rx only, Packaged and Distribut…
FDA Drug · Class II · 2026-04-29 · The Harvard Drug Group - Memantine Hydrochloride Extended-Release, Capsules, 7 mg, 100 Capsules (10 x 10 blister packs), Rx only, Packaged and Distributed by: Major…
FDA Drug · Class II · 2026-04-22 · The Harvard Drug Group - Midodrine Hydrochloride Tablets, USP, 5 mg, 50 Tablets (5 x 10 blister packs), Rx only, Packaged and Distributed by: Major Pharmaceuticals,…
FDA Drug · Class II · 2026-03-11 · The Harvard Drug Group - Gabapentin Capsules, USP, 100 mg, 100 Capsules (10 x 10 blister packs), Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indian…
FDA Drug · Class II · 2025-10-29 · The Harvard Drug Group
All The Harvard Drug Group recalls
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0227-2025%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.