CLASS II ONGOING Drug recall · Reported 26 Feb 2025 · FDA Enforcement Report

Lorazepam Tablets, USP, 1mg, Unit Dose per carton ( blister packs) recalled

The Harvard Drug Group is recalling Lorazepam Tablets, USP, 1mg, Unit Dose per carton ( blister packs), distributed nationwide in the US. The recall was initiated on 21 Jan 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot #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.

Quantity recalled94,349 cartons

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number: D-0227-2025
FDA event ID: 96151
Recalling firm: The Harvard Drug Group, La Vergne, TN
Classification: Class II
Status: Ongoing
Recall initiated: 21 Jan 2025
FDA classified: 19 Feb 2025
Reported: 26 Feb 2025
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Potency & Assay
Drug class: Anxiety & Sleep Medication

Timeline

21 Jan 2025	Recall initiated by company
19 Feb 2025	Classified by FDA	+29 days
26 Feb 2025	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.

Product as listed by the FDA

Lorazepam Tablets, USP, 1mg, Unit Dose, 100 tablets per carton (10 x 10 blister packs), Rx only, The drug product contained in this package is from NDC # 69315-905 Leading Pharma, LLC., Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 26268 USA, NDC: 0904-6008-61.

Where it was distributed

Nationwide U.S. and Puerto rico

Nationwide Puerto Rico

Questions about this recall

Is Lorazepam Tablets, USP, 1mg, Unit Dose per carton ( blister packs) recalled?

Yes. The Harvard Drug Group recalled Lorazepam Tablets, USP, 1mg, Unit Dose per carton ( blister packs) on 21 Jan 2025. The recall is Class II and its status is Ongoing. Recall number D-0227-2025.

Why was it recalled?

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

Which lots are affected?

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.

Where was it sold?

Nationwide U.S. and Puerto rico

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from The Harvard Drug Group

All 79

Reported	Class	Recall	Company	Reason	Where
1 Jul 2026Drug	CLASS II	Carton Label: Major, Methylergonovine Maleate Tablets recalledMethylergonovine Maleate	The Harvard Drug Group	Potency & Assay	Nationwide
29 Apr 2026Drug	CLASS II	Omega-3-Acid, Ethyl Esters, Capsules recalled by The Harvard Drug GroupOmega-3-acid Ethyl Esters	The Harvard Drug Group	Potency & Assay	Nationwide
22 Apr 2026Drug	CLASS II	Memantine Hydrochloride Extended-Release, Capsules, 7 mg recalledMemantine Hydrochloride	The Harvard Drug Group	Potency & Assay	Nationwide
11 Mar 2026Drug	CLASS II	Midodrine Hydrochloride Tablets, USP, 5 mg ( blister packs) recalledMidodrine Hydrochloride	The Harvard Drug Group	Packaging Defects	Nationwide
29 Oct 2025Drug	CLASS II	Gabapentin Capsules, USP, 100 mg ( blister packs) recalledGabapentin	The Harvard Drug Group	Potency & Assay	Nationwide

Other Lorazepam recalls

All 14

Reported	Class	Recall	Company	Reason	Where
6 Aug 2025Drug	CLASS II	Lorazepam Injection, USP, 2 mg/mL, 25 x vials/carton recalledLorazepam	Hikma Pharmaceuticals USA	Potency & Assay	Nationwide
26 Feb 2025Drug	CLASS II	Lorazepam Tablets, USP, 2mg, Unit Dose per carton ( blister packs) recalled	The Harvard Drug Group	Potency & Assay	Nationwide
26 Feb 2025Drug	CLASS II	Lorazepam Tablets, USP, 5mg, Unit Dose per carton ( blister packs) recalled	The Harvard Drug Group	Potency & Assay	Nationwide
7 Jun 2023Drug	CLASS II	Lorazepam Oral Concentrate, USP, 2mg per mL recalled by Akorn	Akorn	Sterility	Nationwide
7 Jun 2023Drug	CLASS II	Lorazepam Injection, USP 2 mg/mL vial vials recalled by Akorn	Akorn	Sterility	Nationwide