The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-0228-2025·Announced 2025-02-26

Lorazepam tablets recalled due to failed potency and impurity specifications

The Harvard Drug Group LLC is recalling Lorazepam 2mg tablets due to out-of-specification results in potency and impurity testing. Affected products were distributed nationwide.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall for sub-potent drug product with failed impurity and degradation specifications. While no illnesses or injuries have been reported, sub-potent benzodiazepines present a risk of inadequate treatment for patients with anxiety or seizure disorders.

Plain-English summary

Lorazepam 2mg unit-dose tablets are being recalled by The Harvard Drug Group LLC due to failed potency and impurity testing. During routine stability testing, out-of-specification results were identified in Assay and Impurities, resulting in sub-potent drug product.

The recall affects 27,525 cartons distributed nationwide in the U.S. and Puerto Rico. The recalled lots include: N01422, N01423 (Exp 03/31/2025); N01661, N01662 (Exp 09/30/2025); N01746, N01750 (Exp 10/31/2025); N01876, N01877 (Exp 03/31/2026); and N01899, N01900, N01975 (Exp 04/30/2026). Patients who have received product from these recalled lots should consult their healthcare provider regarding their medication and treatment plan.

The recalled product

Product
LORAZEPAM (LORAZEPAM)
Brand
LORAZEPAM
Manufacturer
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
Category
Drug — Benzodiazepine
Hazard
Affected units
27,525

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (16)

  • 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.

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 3 recalled by The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

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