Chlorpromazine Hydrochloride Tablet, Film Coated
FDA Recall NDC 69238-1060
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 4 recorded enforcement report(s) associated with Chlorpromazine Hydrochloride (NDC 69238-1060). A significant event, classified as Class II, was initiated on Aug 18, 2025 by Amneal Pharmaceuticals Ny Llc. The reported reason for this action was: "Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets."
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
August 2025 Class II Recall: Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
Recall Number
Class II Ongoing
Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
Aug 18, 2025
Sep 10, 2025
7,228 100-count bottles
Recall Profile & Regulatory Data
Event ID
97438
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Amneal Pharmaceuticals, LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Distributed Nationwide in the USA
Product Description
chlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 100-count bottles, Rx Only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit, Ahmedabad 382213, INDIA, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807, NDC 69238-1056-1.
Batch or Lot Expiration Information
Lot# Lot AM240617, AM240618, Exp Date 04/30/2027
Affected Packages Involved in this Recall
69238-1054-1Product
69238-1056-1Product
69238-1058-1Product
69238-1060-1Product
69238-1062-1Product
August 2025 Class II Recall: Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
Recall Number
Class II Ongoing
Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
Aug 18, 2025
Sep 10, 2025
13,130 100-count bottles
Recall Profile & Regulatory Data
Event ID
97438
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Amneal Pharmaceuticals, LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Distributed Nationwide in the USA
Product Description
chlorproMAZINE Hydrochloride Tablets, USP, 50 mg, 100-count bottle, Rx Only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit, Ahmedabad 382213, INDIA; Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807, NDC 69238-1058-1.
Batch or Lot Expiration Information
Lot# Lot: AM240147, AM240148, Exp Date 01/31/2027; Lot AM240664, AM240665, Exp Date 04/30/2027.
Affected Packages Involved in this Recall
69238-1054-1Product
69238-1056-1Product
69238-1058-1Product
69238-1060-1Product
69238-1062-1Product
August 2025 Class II Recall: Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
Recall Number
Class II Ongoing
Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
Aug 18, 2025
Sep 10, 2025
3,363 100-count bottles
Recall Profile & Regulatory Data
Event ID
97438
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Amneal Pharmaceuticals, LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Distributed Nationwide in the USA
Product Description
chlorproMAZINE Hydrochloride Tablets, USP, 200 mg, 100-count bottles Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit, Ahmedabad 382213, INDIA; Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807, NDC 69238-1062-1.
Batch or Lot Expiration Information
Lot# Lot: AM240336, AM240337, Exp Date 02/28/2027.
Affected Packages Involved in this Recall
69238-1054-1Product
69238-1056-1Product
69238-1058-1Product
69238-1060-1Product
69238-1062-1Product
August 2025 Class II Recall: Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
Recall Number
Class II Ongoing
Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
Aug 18, 2025
Sep 10, 2025
14,923 100-count bottles
Recall Profile & Regulatory Data
Event ID
97438
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Amneal Pharmaceuticals, LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Distributed Nationwide in the USA
Product Description
chlorproMAZINE Hydrochloride Tablets, USP, 100 mg, 100-count bottle, Rx Only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit, Ahmedabad 382213, INDIA; Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807, NDC 69238-1060-1.
Batch or Lot Expiration Information
Lot# Lot: AM240334, AM240335, Exp Date 02/28/2027, AM241031, Exp Date 06/30/2027.
Affected Packages Involved in this Recall
69238-1054-1Product
69238-1056-1Product
69238-1058-1Product
69238-1060-1Product
69238-1062-1Product
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.
