Chlorpromazine Hydrochloride Tablet, Film Coated
FDA Recall NDC 70710-1129
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 6 recorded enforcement report(s) associated with Chlorpromazine Hydrochloride (NDC 70710-1129). A significant event, classified as Class II, was initiated on Sep 03, 2025 by Zydus Pharmaceuticals (usa) Inc.. The reported reason for this action was: "CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable 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 acceptable intake limit
Sep 03, 2025
Sep 17, 2025
N/A
Recall Profile & Regulatory Data
Event ID
97534
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Zydus Pharmaceuticals (USA) Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Product Description
Chlorpromazine Hydrochloride Tablets, USP, 10 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India; Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534. NDC: 70710-1129-1
Batch or Lot Expiration Information
Lot# : Z403012, Exp Date 30-04-26; Z406657, Exp Date 30-11-26
Affected Packages Involved in this Recall
70710-1129-1Product
70710-1129-2Product
70710-1129-4Product
70710-1130-1Product
70710-1130-2Product
70710-1130-4Product
70710-1131-1Product
70710-1131-2Product
70710-1131-4Product
70710-1132-1Product
70710-1132-2Product
70710-1132-4Product
70710-1133-1Product
70710-1133-2Product
70710-1133-4Product
Class II Ongoing
CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
Sep 03, 2025
Sep 17, 2025
N/A
Recall Profile & Regulatory Data
Event ID
97534
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Zydus Pharmaceuticals (USA) Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Product Description
Chlorpromazine Hydrochloride Tablets, USP, 100 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India; Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534. NDC: 70710-1132-1
Batch or Lot Expiration Information
Lot# : Z305079, Z305080, Exp Date 30-09-25; Z305454, Z305455, Z305457, Z400492, Z400493, Z400494, Exp Date 31-12-25; Z401158, Z401725, Z401726, Exp. Date 28-02-26; Z404118, Z404119, Z404120, Exp Date 30-06-26; Z405648, Exp Date 30-09-26
Affected Packages Involved in this Recall
70710-1129-1Product
70710-1129-2Product
70710-1129-4Product
70710-1130-1Product
70710-1130-2Product
70710-1130-4Product
70710-1131-1Product
70710-1131-2Product
70710-1131-4Product
70710-1132-1Product
70710-1132-2Product
70710-1132-4Product
70710-1133-1Product
70710-1133-2Product
70710-1133-4Product
Class II Ongoing
CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
Sep 03, 2025
Sep 17, 2025
N/A
Recall Profile & Regulatory Data
Event ID
97534
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Zydus Pharmaceuticals (USA) Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Product Description
Chlorpromazine Hydrochloride Tablets, USP, 50 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India; Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534. NDC: 70710-1131-1
Batch or Lot Expiration Information
Lot# : Z306327, Exp Date 30-11-25; Z306748, Exp Date 30-11-25; Z401154, Exp Date 28-02-26; Z403738, Exp Date 31-05-26; Z405645, Exp Date 30-09-26
Affected Packages Involved in this Recall
70710-1129-1Product
70710-1129-2Product
70710-1129-4Product
70710-1130-1Product
70710-1130-2Product
70710-1130-4Product
70710-1131-1Product
70710-1131-2Product
70710-1131-4Product
70710-1132-1Product
70710-1132-2Product
70710-1132-4Product
70710-1133-1Product
70710-1133-2Product
70710-1133-4Product
Class II Ongoing
CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
Sep 03, 2025
Sep 17, 2025
N/A
Recall Profile & Regulatory Data
Event ID
97534
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Zydus Pharmaceuticals (USA) Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Product Description
Chlorpromazine Hydrochloride Tablets, USP, 25 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India; Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534. NDC: 70710-1130-1
Batch or Lot Expiration Information
Lot# : Z305060, Z305061, Exp Date 31-08-25; Z306323, Exp Date 30-11-25; Z401153, Exp Date 28-02-26; Z403015, Z403016, Exp Date 30-04-26; Z405591, Exp Date 30-09-26
Affected Packages Involved in this Recall
70710-1129-1Product
70710-1129-2Product
70710-1129-4Product
70710-1130-1Product
70710-1130-2Product
70710-1130-4Product
70710-1131-1Product
70710-1131-2Product
70710-1131-4Product
70710-1132-1Product
70710-1132-2Product
70710-1132-4Product
70710-1133-1Product
70710-1133-2Product
70710-1133-4Product
Class II Ongoing
CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
Sep 03, 2025
Sep 17, 2025
N/A
Recall Profile & Regulatory Data
Event ID
97534
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Zydus Pharmaceuticals (USA) Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Product Description
Chlorpromazine Hydrochloride Tablets, USP, 200 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India; Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534. NDC: 70710-1133-1
Batch or Lot Expiration Information
Lot# : Z305083, Z305084, Z305468, Z305469, Z305470, Exp Date 30-09-25; Z401163, Z401165, Exp Date 28-02-26; Z402217, Z402218, Exp Date 31-03-26; Z405518, Z405520, Exp Date 31-08-26; Z406235, Exp Date 31-10-26
Affected Packages Involved in this Recall
70710-1129-1Product
70710-1129-2Product
70710-1129-4Product
70710-1130-1Product
70710-1130-2Product
70710-1130-4Product
70710-1131-1Product
70710-1131-2Product
70710-1131-4Product
70710-1132-1Product
70710-1132-2Product
70710-1132-4Product
70710-1133-1Product
70710-1133-2Product
70710-1133-4Product
Class II Ongoing
CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit
Apr 03, 2025
Apr 16, 2025
3144 bottles, pack size: 100's Count
Recall Profile & Regulatory Data
Event ID
96626
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Zydus Pharmaceuticals (USA) Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within U.S - MS, AL, TN, VT, OH, ND, MN, WI, SC, AR, FL, IN, LA, NJ, AZ, TX, KY and PA
Product Description
chlorproMAZINE Hydrochloride Tablets, USP 10 mg, Rx Only, 100 Tablets bottles, Manufactured by: Zydus Lifesciences Ltd., Baddi, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 70710-1129-1
Batch or Lot Expiration Information
Lot# : Z400069, Exp.: 12/31/2025
Affected Packages Involved in this Recall
70710-1129-1Product
70710-1129-2Product
70710-1129-4Product
70710-1130-1Product
70710-1130-2Product
70710-1130-4Product
70710-1131-1Product
70710-1131-2Product
70710-1131-4Product
70710-1132-1Product
70710-1132-2Product
70710-1132-4Product
70710-1133-1Product
70710-1133-2Product
70710-1133-4Product
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.
