Lorazepam Tablets recall: Impurity Out of Spec
Lorazepam Tablets, USP, 2mg, Unit Dose, 100 tablets per carton (10 x 10 blister packs), Rx only, The drug product contained in this package is from NDC # 69315-906 Leading Pharma, LLC., Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 26268 USA, NDC: 0904-6009-61.
Why was Lorazepam Tablets recalled?
Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results were obtained during routine stability testing for Assay and Impurities.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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.
- Product
- Lorazepam Tablets, USP, 2mg, Unit Dose, 100 tablets per carton (10 x 10 blister packs), Rx only, The drug product contained in this package is from NDC # 69315-906 Leading Pharma, LLC., Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 26268 USA, NDC: 0904-6009-61.
- Recalling firm
- The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
- Quantity
- 27,525 cartons
- Distribution
- Nationwide U.S. and Puerto rico
- Recall date
- February 26, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (drug)