Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Lorazepam Tablets Recalled by The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories Due to Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories directly.
Affected Products
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
Quantity: 82,281 cartons
Why Was This Recalled?
Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results were obtained during routine stability testing for Assay and Impurities.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories has 24 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report