FDA Recall D-0009-2026

The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories · La Vergne, TN

Class II Ongoing 244 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

Product

Major ChlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 50 Tablets (5x10) blister package, Rx Only, Packaged and Distributed by Major Pharmaceuticals, Indianapolis, IN 46268, USA, NDC 0904-7130-06, UPC (01)00309047130061

Lot / code: Lots N01943 and Lot N02025, exp. date 02/28/2026

Quantity: 2064 blister packs

Reason for recall

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

Recall record

Recall number: D-0009-2026
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Nationwide
Recall initiated: 2025-09-12
Classified by FDA Center: 2025-10-07
FDA published: 2025-10-15
Recalling firm: The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
Firm location: La Vergne, TN

Drug identification

Brand name(s): CHLORPROMAZINE HYDROCHLORIDE
Generic name(s): CHLORPROMAZINE HYDROCHLORIDE
Manufacturer(s): Major Pharmaceuticals
NDC(s): 0904-7132, 0904-7129, 0904-7130, 0904-7131, 0904-7133
Route(s): ORAL

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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