Lorazepam Tablets Recalled for Failed Impurity and Potency Specifications
The FDA is recalling 94,349 cartons of Lorazepam 1mg tablets due to out-of-specification results for impurities and sub-potency discovered during routine stability testing. The affected product was distributed nationwide in the U.S. and 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: This is an FDA Class II recall for out-of-specification results affecting a controlled psychiatric medication. No illnesses or injuries have been reported, but the sub-potency and impurities represent real risks to patient safety, warranting a High severity rating per the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
The FDA is recalling 94,349 cartons of Lorazepam 1mg tablets manufactured by The Harvard Drug Group LLC, doing business as Major Pharmaceuticals and Rugby Laboratories. The product is packaged as unit dose tablets in cartons containing 100 tablets (10 x 10 blister packs) and was distributed nationwide in the U.S. and Puerto Rico.
The recall was initiated due to out-of-specification results obtained during routine stability testing. The product failed to meet established specifications for assay and impurities. Specifically, the tested lots were found to be sub-potent—containing less active pharmaceutical ingredient than required—and to contain impurities and degradation products that failed to meet specifications.
The affected lot numbers are: N01419, N01420, N01421 (expiration 3/31/2025); N01663 (6/30/2025); N01664 (8/31/2025); N01673 (9/30/2025); N01688 (8/31/2025); N01747, N01748, N01749 (11/30/2025); N01792 (12/31/2025); N01857 (2/28/2026); N01974 (5/31/2026); and N02081 (8/31/2026). Patients and healthcare providers should verify whether their Lorazepam supply matches any of these lots. The FDA recall reference number is D-0227-2025.
The recalled product
- Product
- LORAZEPAM (LORAZEPAM)
- Brand
- LORAZEPAM
- Manufacturer
- The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
- Hazard
- sub-potency
- impurities
- 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 (20)
- 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
- N01747
- N01748
- N01749
- Exp 11/30/2025
- N01792
- Exp 12/31/2025
- N01857
- Exp 02/28/2026
- N01974
Distribution
Distributed nationwide across the United States.
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