FDAFDA · Food and drugs·Recall number D-0226-2025
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
Published February 26, 2025 · Recall initiated: January 21, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results were obtained during routine stability testing for Assay and Impurities.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- LORAZEPAM
- Manufacturer
- The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
- Distributor
- Nationwide U.S. and Puerto rico
- 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.
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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