Chlorpromazine Hydrochloride Tablet, Film Coated
FDA Recall NDC 50268-166
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Chlorpromazine Hydrochloride (NDC 50268-166). A significant event, classified as Class II, was initiated on Aug 25, 2025 by Avpak. The reported reason for this action was: "Presence of a foreign substance."
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
Presence of a foreign substance.
Aug 25, 2025
Sep 17, 2025
2003 cartons
Recall Profile & Regulatory Data
Event ID
97548
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
AvKARE
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
USA Nationwide
Product Description
chloroproMAZINE Hydrochloride Tablets, USP, 100 mg, 50 Tablets (5x10) unit dose carton, Rx only, Manufactured for: AvKare, Pulaski, TN, 38478, NDC 50268-165-15
Batch or Lot Expiration Information
Lot# 47089, Exp 12/31/25; 47604, Exp 03/31/26
Affected Packages Involved in this Recall
50268-162-11Product
50268-162-15Product
50268-163-11Product
50268-163-15Product
50268-164-11Product
50268-164-15Product
50268-165-11Product
50268-165-15Product
50268-166-11Product
50268-166-12Product
Class II Ongoing
Presence of a foreign substance.
Aug 25, 2025
Sep 17, 2025
1512 cartons
Recall Profile & Regulatory Data
Event ID
97548
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
AvKARE
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
USA Nationwide
Product Description
chloroproMAZINE Hydrochloride Tablets, USP, 50 mg, 50 Tablets (5x10) unit dose carton, Rx only, Manufactured for: AvKare, Pulaski, TN, 38478, NDC 50268-164-15
Batch or Lot Expiration Information
Lot# 46824, Exp 9/30/25; 47171, Exp 12/31/25
Affected Packages Involved in this Recall
50268-162-11Product
50268-162-15Product
50268-163-11Product
50268-163-15Product
50268-164-11Product
50268-164-15Product
50268-165-11Product
50268-165-15Product
50268-166-11Product
50268-166-12Product
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.
