Drug & Device Safety Atlas

FDA drug recalls · openFDA

Is LORAZEPAM recalled?

The FDA has recorded 5 recalls of LORAZEPAM (2023–2025) , recalled under brand like LORAZEPAM. 4 still ongoing.

0
Class I (most serious)
5
Class II
0
Class III
4
ongoing

A recall doesn't mean your pills are affected

Drug recalls are issued by lot (specific batches, identified by lot numbers / NDC) — not for every bottle of LORAZEPAM ever made. To know if yours is involved, match the lot codes on the recall below against your bottle, or ask your pharmacist. Do not stop a prescribed medication because of a recall without talking to your pharmacist or prescriber — stopping can be more dangerous than the recall. The Class is the FDA's risk judgment (Class I = reasonable probability of serious harm or death), not a measurement that harm occurred; most recalls are voluntary and Class II/III.

Why it was recalled

Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results were obtained during rout 3
Failed Impurities/Degradation Specifications: An out-of-Specification for total related compounds 1
Failed Impurities/Degradation Specifications: Out-of-specification results for total related compounds observed during r 1

The recalls

Class I and ongoing recalls first. Tap a recall for its full record and lot detail.

Lorazepam Tablets, USP, 0.5mg, Unit Dose, 100 tablets per carton (10 x 10 blister packs), Rx only, The drug product cont Class II ongoing
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories 2025-01-21 lots: 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.
Lorazepam Tablets, USP, 1mg, Unit Dose, 100 tablets per carton (10 x 10 blister packs), Rx only, The drug product contai Class II ongoing
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories 2025-01-21 lots: Lot #s: N01419, N01420, N01421, Exp 03/31/2025; N01663, Exp 06/30/2025; N01664, Exp 08/31/2025; N01673, Exp 09/30/2025; N01688, Exp 08/31/2025; N01747, N01748, N01749, Exp 11/30/2025; N01792, Exp 12/31/2025; N01857, Exp 02/28/2026; N01974, Exp 05/31/2026; N02081, Exp 08/31/2026.
Lorazepam Injection, USP, 2 mg/mL, 25 x 1mL vials/carton, Rx Only, Manufactured by: Hikma Berkeley Heights, NJ 07922, N Class II ongoing
Hikma Pharmaceuticals USA Inc. 2025-07-22 lots: Lot # K24118, exp. date 10/31/2026
Lorazepam Tablets, USP, 2mg, Unit Dose, 100 tablets per carton (10 x 10 blister packs), Rx only, The drug product contai Class II ongoing
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories 2025-01-21 lots: 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.
Lorazepam Injection, USP, 2mg/mL, 1 mL vial (NDC 0641-6044-01), packaged in 25 x 1 mL Vials per carton (NDC 0641-6044-25 Class II Terminated
Hikma Pharmaceuticals USA Inc. 2023-05-11 lots: Lots: 070086, 070128, Exp. 07/2023

RECORDED — these are the FDA's published recall enforcement records (openFDA), grouped by the generic drug name. Scope: drug recalls the FDA recorded with a generic name; device recalls and recalls without a generic name are in the full recall browse. "Ongoing" reflects openFDA's last-published status — confirm current status and your lot at the FDA recall database. This page informs and routes; it is not medical advice.

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