Lorazepam Tablets Recalled Due to Sub-Potency and Failed Stability Testing
The Harvard Drug Group is recalling Lorazepam Tablets USP 0.5mg due to sub-potency and failed stability test results. Approximately 82,281 cartons are affected nationwide and in Puerto Rico.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II drug recall involving sub-potency and failed stability specifications in a controlled benzodiazepine medication. Sub-potent lorazepam poses a risk of therapeutic failure; however, no illnesses or injuries have been reported, limiting the severity below Severe per the rubric.
Plain-English summary
The Harvard Drug Group LLC (dba Major Pharmaceuticals and Rugby Laboratories) is recalling Lorazepam Tablets, USP, 0.5mg, distributed nationwide in the U.S. and Puerto Rico. Approximately 82,281 cartons in unit dose packaging are affected.
During routine stability testing, the drug product failed to meet specifications for assay and impurities. Testing revealed the drug to be sub-potent—containing less active ingredient than specified—with out-of-specification results for degradation products. Multiple lot numbers are affected, including N01424, N01425 (expires 03/31/2025), N01659, N01660 (expires 08/31/2025), N01668 (expires 09/2025), N01679, N01704, N01745 (expires 10/31/2025), N01856 (expires 02/28/2026), N01973 (expires 05/31/2026), and N02079 (expires 08/31/2026).
Patients taking Lorazepam should verify the lot number and expiration date of their medication. Those with affected lot numbers should contact their pharmacy or healthcare provider with questions about their supply.
The recalled product
- Product
- LORAZEPAM (LORAZEPAM)
- Brand
- LORAZEPAM
- Manufacturer
- The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
- Category
- Drug — Benzodiazepine
- Hazard
- sub-potent-drug
- degradation
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (18)
- 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.
Distribution
Distributed nationwide across the United States.
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