MedicineWatch US
Class II Recall

The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories

Product
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
Reason
Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results were obtained during routine stability testing for Assay and Impurities.
Classification
Class II
Status
Ongoing
Lot
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.
Date
Disclaimer: This tool indexes published US FDA drug-enforcement recall records from all countries, limited to the latest five years. A company or product not appearing here is not proof that it is compliant, approved, safe, or free of FDA action.