Chlorpromazine Hydrochloride Tablet, Film Coated
FDA Recall NDC 60687-430
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 60687-430). A significant event, classified as Class II, was initiated on Aug 27, 2025 by American Health Packaging. The reported reason for this action was: "Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging at the manufacturing site, 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 at the manufacturing site, 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 at the manufacturing site, was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
Aug 27, 2025
Sep 24, 2025
1,062 cartons
Recall Profile & Regulatory Data
Event ID
97533
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Amerisource Health Services LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Product Description
chlorproMAZINE Hydrochloride Tablets, USP, 50 mg, 100 (10x10) blisterpacks, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. 50 Tablet Carton NDC#: 60687-441-01 (Individual Dose NDC: 60687-441-11)
Batch or Lot Expiration Information
Lot# Lot: 1022159, exp 12/31/2026; 1023299, exp 03/31/2027; 1024057, Exp 04/30/2027
Affected Packages Involved in this Recall
60687-419-11Product
60687-419-01Product
60687-430-11Product
60687-430-01Product
60687-430-65Product
60687-441-11Product
60687-441-01Product
60687-452-11Product
60687-452-01Product
60687-463-11Product
60687-463-01Product
August 2025 Class II Recall: Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging at the manufacturing site, 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 at the manufacturing site, was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
Aug 27, 2025
Sep 24, 2025
1,757 cartons
Recall Profile & Regulatory Data
Event ID
97533
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Amerisource Health Services LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Product Description
chlorproMAZINE Hydrochloride Tablets, USP, 100 mg, 100 (10x10) blisterpack per carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. Carton NDC#: 60687-452-01 (Individual unit dose blister pack NDC: 60687-452-11)
Batch or Lot Expiration Information
Lot# Lot: 1021652, Exp 10/31/2026; 1022539, Exp 01/31/2027; 1023666, Exp 03/31/2027
Affected Packages Involved in this Recall
60687-419-11Product
60687-419-01Product
60687-430-11Product
60687-430-01Product
60687-430-65Product
60687-441-11Product
60687-441-01Product
60687-452-11Product
60687-452-01Product
60687-463-11Product
60687-463-01Product
August 2025 Class II Recall: Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging at the manufacturing site, 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 at the manufacturing site, was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
Aug 27, 2025
Sep 24, 2025
2,708 cartons
Recall Profile & Regulatory Data
Event ID
97533
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Amerisource Health Services LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Product Description
chlorproMAZINE Hydrochloride Tablets, USP, 25 mg, packaged as a) 50 (5x10) blisterpacks, NDC: 60687-430-65; (Individual Dose NDC: 60687-430-11); b) 100 (10x10) blisterpacks, NDC: 60687-430-01, (Individual Dose NDC: 60687-430-11), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217.
Batch or Lot Expiration Information
Lot# Lot: a)1020919, 1021133, Exp 09/30/2026; 1021447, Exp 10/31/2026; 1021741, 1022202, Exp 11/30/2026; 1022474, Exp 12/31/2026 Lot: b) 1020460, exp 08/31/2026; 1022417, exp 12/31/2026
Affected Packages Involved in this Recall
60687-419-11Product
60687-419-01Product
60687-430-11Product
60687-430-01Product
60687-430-65Product
60687-441-11Product
60687-441-01Product
60687-452-11Product
60687-452-01Product
60687-463-11Product
60687-463-01Product
August 2025 Class II Recall: Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging at the manufacturing site, 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 at the manufacturing site, was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
Aug 27, 2025
Sep 24, 2025
873 cartons
Recall Profile & Regulatory Data
Event ID
97533
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Amerisource Health Services LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Product Description
chlorproMAZINE Hydrochloride Tablets, USP, 200 mg, 100 (10x10) blisterpack per carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC#: 60687-463-01 (Individual Dose NDC: 60687-463-11)
Batch or Lot Expiration Information
Lot# Lot: 1021640, Exp 10/31/2026; 1022639, Exp 01/31/2027
Affected Packages Involved in this Recall
60687-419-11Product
60687-419-01Product
60687-430-11Product
60687-430-01Product
60687-430-65Product
60687-441-11Product
60687-441-01Product
60687-452-11Product
60687-452-01Product
60687-463-11Product
60687-463-01Product
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.
