Lorazepam tablets recalled due to failed potency and impurity specifications
The Harvard Drug Group LLC is recalling Lorazepam 2mg tablets due to out-of-specification results in potency and impurity testing. Affected products were distributed nationwide.
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 recall for sub-potent drug product with failed impurity and degradation specifications. While no illnesses or injuries have been reported, sub-potent benzodiazepines present a risk of inadequate treatment for patients with anxiety or seizure disorders.
Plain-English summary
Lorazepam 2mg unit-dose tablets are being recalled by The Harvard Drug Group LLC due to failed potency and impurity testing. During routine stability testing, out-of-specification results were identified in Assay and Impurities, resulting in sub-potent drug product.
The recall affects 27,525 cartons distributed nationwide in the U.S. and Puerto Rico. The recalled lots include: N01422, N01423 (Exp 03/31/2025); N01661, N01662 (Exp 09/30/2025); N01746, N01750 (Exp 10/31/2025); N01876, N01877 (Exp 03/31/2026); and N01899, N01900, N01975 (Exp 04/30/2026). Patients who have received product from these recalled lots should consult their healthcare provider regarding their medication and treatment plan.
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-potency
- degradation-impurity
- out-of-spec
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 (16)
- Lot #s: N01422
- N01423
- Exp 03/31/2025
- N01661
- N01662
- Exp 09/30/2025
- N01746
- N01750
- Exp 10/31/2025
- N01876
- N01877
- Exp 03/31/2026
- N01899
- N01900
- N01975
- Exp 04/30/2026.
Distribution
Distributed nationwide across the United States.
Related recalls
Same brand · LORAZEPAM
- HighLorazepam Tablets Recalled Due to Sub-Potency and Failed Stability Testing
FDA (Drugs) · 2025-02-26
- HighLorazepam Tablets Recalled for Failed Impurity and Potency Specifications
FDA (Drugs) · 2025-02-26
- HighLorazepam injection vials recalled for elevated impurities and degradation
FDA (Drugs) · 2023-05-24
- HighLorazepam injection vials recalled nationwide for manufacturing specification failures
FDA (Drugs) · 2022-08-17
- HighLorazepam Injection Recalled for Out-of-Specification Impurities and Degradation
FDA (Drugs) · 2022-08-17
Same category
- CriticalWarfarin Tablets Recalled After Mix-Up Between 2.5 mg and 5 mg Strengths
FDA (Drugs) · 2026-07-21
- HighBeak & Skiff Alcohol Antiseptic Sanitizer recalled for acetaldehyde contamination
FDA (Drugs) · 2026-06-17
- SevereCIMZIA injection recalled due to lack of sterility assurance
FDA (Drugs) · 2026-05-27
- SevereAtomoxetine Capsules Recalled Due to Labeling Mix-Up Error
FDA (Drugs) · 2026-05-27
- LowPrimidone Tablets Recalled Due to Cross-Contamination with Acemetacin
FDA (Drugs) · 2026-05-27