Chlorpromazine Hydrochloride
FDA Recall NDC 0904-7129
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.
The FDA has identified 6 recorded enforcement report(s) associated with Chlorpromazine Hydrochloride (NDC 0904-7129). A significant event, classified as Class II, was initiated on Sep 12, 2025 by Major Pharmaceuticals. The reported reason for this action was: "CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit"
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class II Ongoing
CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit
Sep 12, 2025
Oct 15, 2025
1256 blister packs
Recall Profile & Regulatory Data
Event ID
97584
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Product Description
Major ChlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 100 Tablets (10x10) blister package, Rx Only, Packaged and Distributed by Major Pharmaceuticals, Indianapolis, IN 46268, USA, NDC 0904-7130-61, UPC (01)00309047130610
Batch or Lot Expiration Information
Lot# Lots N01954, Exp. Date, 11/30/2025 & N02024, Exp. Date, 02/28/2026
Affected Packages Involved in this Recall
0904-7129-61Product
0904-7130-61Product
0904-7130-06Product
0904-7131-61Product
0904-7132-61Product
0904-7133-61Product
0030904713Product
Class II Ongoing
CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit
Sep 12, 2025
Oct 15, 2025
1394 blister packs
Recall Profile & Regulatory Data
Event ID
97584
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Product Description
Major ChlorproMAZINE Hydrochloride Tablets, USP, 200 mg, 100 Tablets (10x10) blister package, Rx Only, Packaged and Distributed by Major Pharmaceuticals, Indianapolis, IN 46268, USA, NDC 0904-7133-61, UPC (01)00309047133611 NDC 0904-7133-61
Batch or Lot Expiration Information
Lot# Lots N01928, Exp. Date, 09/30/2025, N02008, Exp. Date, 03/21/2026 & N02071, Exp. Date 02/28/2026
Affected Packages Involved in this Recall
0904-7129-61Product
0904-7130-61Product
0904-7130-06Product
0904-7131-61Product
0904-7132-61Product
0904-7133-61Product
0030904713Product
Class II Ongoing
CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit
Sep 12, 2025
Oct 15, 2025
2064 blister packs
Recall Profile & Regulatory Data
Event ID
97584
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Product Description
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
Batch or Lot Expiration Information
Lot# Lots N01943 and Lot N02025, exp. date 02/28/2026
Affected Packages Involved in this Recall
0904-7129-61Product
0904-7130-61Product
0904-7130-06Product
0904-7131-61Product
0904-7132-61Product
0904-7133-61Product
0030904713Product
Class II Ongoing
CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit
Sep 12, 2025
Oct 15, 2025
866 blister packs
Recall Profile & Regulatory Data
Event ID
97584
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Product Description
Major ChlorproMAZINE Hydrochloride Tablets, USP, 100 mg, 100 Tablets (10x10) blister package, Rx Only, Packaged and Distributed by Major Pharmaceuticals, Indianapolis, IN 46268, USA, NDC 0904-7132-61, UPC (01)00309047132614
Batch or Lot Expiration Information
Lot# Lots N01920, Exp. Date, 12/31/2025, N02023, Exp. Date, 02/28/2026 & N02202, Exp. Date, 06/30/2026
Affected Packages Involved in this Recall
0904-7129-61Product
0904-7130-61Product
0904-7130-06Product
0904-7131-61Product
0904-7132-61Product
0904-7133-61Product
0030904713Product
Class II Ongoing
CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit
Sep 12, 2025
Oct 15, 2025
506 blister packs
Recall Profile & Regulatory Data
Event ID
97584
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Product Description
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
Batch or Lot Expiration Information
Lot# Lots N02009 & N02026, exp. date 02/28/2026
Affected Packages Involved in this Recall
0904-7129-61Product
0904-7130-61Product
0904-7130-06Product
0904-7131-61Product
0904-7132-61Product
0904-7133-61Product
0030904713Product
Class II Ongoing
CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit
Apr 14, 2025
Apr 23, 2025
133 cartons
Recall Profile & Regulatory Data
Event ID
96679
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide USA
Product Description
ChlorproMAZINE Hydrochloride Tablets, USP, 10 mg, packaged in cartons of 100 TABLETS (10x10), Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268, NDC 0904-7129-61
Batch or Lot Expiration Information
Lot# : N02114, Exp 12/31/2025
Affected Packages Involved in this Recall
0904-7129-61Product
0904-7130-61Product
0904-7130-06Product
0904-7131-61Product
0904-7132-61Product
0904-7133-61Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
