Chlorpromazine Hydrochloride Tablet, Film Coated
FDA Recall NDC 68462-862
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 3 recorded enforcement report(s) associated with Chlorpromazine Hydrochloride (NDC 68462-862). A significant event, classified as Class II, was initiated on Mar 11, 2025 by Glenmark Pharmaceuticals Inc., Usa. The reported reason for this action was: "CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim 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: N-Nitroso-Desmethyl Chlorpromazine impurity (NNDCI) were found to be failing per current FDA recommended limit.
Dec 11, 2024
Jan 01, 2025
N/A
Recall Profile & Regulatory Data
Event ID
95936
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Glenmark Pharmaceuticals Inc., USA
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
USA Nationwide
Product Description
chlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 100-count bottle, RX only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ; Product of India, NDC 68462-862-01
Batch or Lot Expiration Information
Lot# : 17230133, Exp 12/31/2024
Affected Packages Involved in this Recall
68462-861-01Product
68462-861-10Product
68462-862-01Product
68462-862-10Product
68462-863-01Product
68462-863-10Product
68462-864-01Product
68462-864-10Product
68462-865-01Product
68462-865-10Product
Class II Ongoing
CGMP Deviations: N-Nitroso-Desmethyl Chlorpromazine impurity (NNDCI) were found to be failing per current FDA recommended limit.
Dec 11, 2024
Jan 01, 2025
3,888
Recall Profile & Regulatory Data
Event ID
95936
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Glenmark Pharmaceuticals Inc., USA
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
USA Nationwide
Product Description
chlorproMAZINE Hydrochloride Tablets, USP, 10mg, 100-count bottle, RX only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ; Product of India, NDC 68462-861-01
Batch or Lot Expiration Information
Lot# : 17230132, Exp 12/2024; 17230449, Exp 01/2025
Affected Packages Involved in this Recall
68462-861-01Product
68462-861-10Product
68462-862-01Product
68462-862-10Product
68462-863-01Product
68462-863-10Product
68462-864-01Product
68462-864-10Product
68462-865-01Product
68462-865-10Product
Class II Ongoing
CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit.
Mar 11, 2025
Apr 09, 2025
8160 bottles
Recall Profile & Regulatory Data
Event ID
95658
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Glenmark Pharmaceuticals Inc., USA
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA and PR
Product Description
chlorproMAZINE Hydrochloride Tablets, USP 100 mg, Rx Only, 100 Tablets per bottle, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, Product of India, NDC 68462-864-01
Batch or Lot Expiration Information
Lot# s: 17232222 and 17232237, Exp 10/31/2025
Affected Packages Involved in this Recall
68462-861-01Product
68462-861-10Product
68462-862-01Product
68462-862-10Product
68462-863-01Product
68462-863-10Product
68462-864-01Product
68462-864-10Product
68462-865-01Product
68462-865-10Product
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.
