Clomipramine Hydrochloride Capsule
FDA Recall NDC 16714-849
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 Clomipramine Hydrochloride (NDC 16714-849). A significant event, classified as Class II, was initiated on Oct 22, 2025 by Northstar Rx Llc.. The reported reason for this action was: "cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA 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: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA acceptable intake limit.
Oct 22, 2025
Nov 12, 2025
N/A
Recall Profile & Regulatory Data
Event ID
97856
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Zydus Pharmaceuticals (USA) Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the US
Product Description
clomiPRAMINE Hydrochloride, Capsules, USP, 25 mg, packaged in a) 30-count bottles (NDC 16714-849-01), b) 90-count bottles (NDC 16714-849-02), c) 100-count bottles (NDC 16714-849-03), Rx only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India
Batch or Lot Expiration Information
Lot# a)
Lot# E408871, Exp Date: 10/2026
Lot# E405282, Exp Date: 06/2026
Lot# E400386, Exp Date: 12/2025 b)
Lot# E408872, Exp Date: 10/2026
Lot# E405280, Exp Date: 06/2026 c)
Lot# E408873, Exp Date: 10/2026
Lot# E405281, Exp Date: 06/2026
Lot# E400387, Exp Date: 12/2025
Affected Packages Involved in this Recall
16714-849-02Product
16714-849-01Product
16714-849-03Product
16714-850-01Product
16714-850-03Product
16714-850-02Product
16714-851-01Product
16714-851-03Product
16714-851-02Product
Class II Ongoing
cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA acceptable intake limit.
Oct 22, 2025
Nov 12, 2025
N/A
Recall Profile & Regulatory Data
Event ID
97856
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Zydus Pharmaceuticals (USA) Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the US
Product Description
clomiPRAMINE Hydrochloride, Capsules, USP, 50 mg, packaged in a) 30-count bottles (NDC 16714-850-01), b) 90-count bottles (NDC 16714-850-02), c) 100-count bottles (NDC 16714-850-03), Rx only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India
Batch or Lot Expiration Information
Lot# a)
Lot# E410157, Exp Date: 12/2026
Lot# E407176, Exp Date: 08/2026
Lot# E405845, Exp Date: 06/2026
Lot# E400943, Exp Date: 01/2026 b)
Lot# E410156, Exp Date: 12/2026
Lot# E400942, Exp Date: 01/2026 c)
Lot# E410158, Exp Date: 12/2026
Lot# E407128, Exp Date: 08/2026
Lot# E405846, Exp Date: 06/2026
Lot# E400944, Exp Date: 01/2026
Affected Packages Involved in this Recall
16714-849-02Product
16714-849-01Product
16714-849-03Product
16714-850-01Product
16714-850-03Product
16714-850-02Product
16714-851-01Product
16714-851-03Product
16714-851-02Product
Class II Ongoing
cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA acceptable intake limit.
Oct 22, 2025
Nov 12, 2025
N/A
Recall Profile & Regulatory Data
Event ID
97856
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Zydus Pharmaceuticals (USA) Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the US
Product Description
clomiPRAMINE Hydrochloride, Capsules, USP, 75 mg, packaged in a) 30-count bottles (NDC 16714-851-01), b) 90-count bottles (NDC 16714-851-02), c) 100 capsules, NDC 16714-851-03 Rx only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India.
Batch or Lot Expiration Information
Lot# a)
Lot# E403069, Exp Date: 04/2026
Lot# E406504, Exp Date: 07/2026
Lot# E309177, Exp Date: 11/2025
Lot# E400262, Exp Date: 12/2025
Lot# E404200, Exp Date: 05/2026 b)
Lot# E403070, Exp Date: 04/2026
Lot# E406505, Exp Date: 07/2026
Lot# E407631, Exp Date: 08/2026
Lot# E400263, Exp Date: 12/2025
Lot# E404202, Exp Date: 05/2026 c)
Lot# E403071, Exp Date: 04/2026
Lot# E407632, Exp Date: 08/2026
Lot# E405848, E405284, Exp Date: 07/2026
Lot# E400264, Exp Date: 12/2025
Lot# E404201, Exp Date: 05/2026
Affected Packages Involved in this Recall
16714-849-02Product
16714-849-01Product
16714-849-03Product
16714-850-01Product
16714-850-03Product
16714-850-02Product
16714-851-01Product
16714-851-03Product
16714-851-02Product
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.
