CLASS II ONGOING Drug recall · Reported 15 Oct 2025 · FDA Enforcement Report

Major ChlorproMAZINE Hydrochloride Tablets, USP, 50 mg recalled

The Harvard Drug Group is recalling Major ChlorproMAZINE Hydrochloride Tablets, USP, 50 mg, blister package, distributed nationwide in the US. The recall was initiated on 12 Sep 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLots N02009 & N02026, exp. date 02/28/2026

Quantity recalled506 blister packs

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-0011-2026
FDA event ID: 97584
Recalling firm: The Harvard Drug Group, La Vergne, TN
Classification: Class II
Status: Ongoing
Recall initiated: 12 Sep 2025
FDA classified: 7 Oct 2025
Reported: 15 Oct 2025
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Nitrosamine Impurity

Timeline

12 Sep 2025	Recall initiated by company
7 Oct 2025	Classified by FDA	+25 days
15 Oct 2025	Published in enforcement report	+8 days

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

Reason for recall

CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit

Nitrosamines are impurities that can form during drug manufacturing or storage. Above the FDA acceptable intake limit, long-term exposure may raise cancer risk. The FDA advises patients to keep taking the medicine until they have a replacement.

Product as listed by the FDA

Major ChlorproMAZINE Hydrochloride Tablets, USP, 50 mg, 100 Tablets, (10x10) blister package, Rx Only, Packaged and Distributed by Major Pharmaceuticals, Indianapolis, IN 46268, USA, NDC 0904-7131-61, UPC (01)00309047131617

Where it was distributed

Nationwide

Questions about this recall

Why was it recalled?

CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit

Which lots are affected?

Lots N02009 & N02026, exp. date 02/28/2026

Where was it sold?

Nationwide

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

Other products in this recall event

4 other products · FDA event 97584

This product is part of a recall event; the main page for the event is Major ChlorproMAZINE Hydrochloride Tablets recalled.

Reported	Class	Recall	Company	Reason	Where
15 Oct 2025	CLASS II	Major ChlorproMAZINE Hydrochloride Tablets recalled	The Harvard Drug Group	Nitrosamine Impurity	Nationwide
15 Oct 2025	CLASS II	Major ChlorproMAZINE Hydrochloride Tablets recalled	The Harvard Drug Group	Nitrosamine Impurity	Nationwide
15 Oct 2025	CLASS II	Major ChlorproMAZINE Hydrochloride Tablets recalled	The Harvard Drug Group	Nitrosamine Impurity	Nationwide
15 Oct 2025	CLASS II	Major ChlorproMAZINE Hydrochloride Tablets recalled	The Harvard Drug Group	Nitrosamine Impurity	Nationwide

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 Major Chlorpromazine recalls

All 5

Reported	Class	Recall	Company	Reason	Where
15 Oct 2025Drug	CLASS II	Major ChlorproMAZINE Hydrochloride Tablets recalled	The Harvard Drug Group	Nitrosamine Impurity	Nationwide
15 Oct 2025Drug	CLASS II	Major ChlorproMAZINE Hydrochloride Tablets recalled	The Harvard Drug Group	Nitrosamine Impurity	Nationwide
15 Oct 2025Drug	CLASS II	Major ChlorproMAZINE Hydrochloride Tablets recalled	The Harvard Drug Group	Nitrosamine Impurity	Nationwide
15 Oct 2025Drug	CLASS II	Major ChlorproMAZINE Hydrochloride Tablets recalled	The Harvard Drug Group	Nitrosamine Impurity	Nationwide