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Drug FDA Class II Ongoing Failed specifications

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

The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories Published Feb 26, 2025

Risk level

Class II

May cause a temporary or reversible health problem; slight chance of serious harm.

Severity score 60/100

What should you do?

  • Check whether you have this product, using the lot codes, UPCs, and dates listed below.
  • Do not eat, serve, or sell the affected product.
  • Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
  • Contact The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories or your place of purchase with questions, and see the source record below for full details.
Reason for recall

Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results were obtained during routine stability testing for Assay and Impurities.

Hazards

Failed Assay and Impurities Specifications · primary

Affected products (1)

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

LORAZEPAM · 82,281 cartons

NDC: 0904-6007, 0904-6008, 0904-6009, 0904-6007-60, 0904-6007-61, 0904-6008-60, 0904-6008-61, 0904-6009-60, 0904-6009-61
Code info: 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.

Affected areas

Nationwide

Timeline

  1. Initiated
    Jan 21, 2025
  2. Published
    Feb 26, 2025
Recall number
D-0226-2025
Agency
U.S. Food and Drug Administration
Country
US
Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.