Multi-event October 2025 FDA Recall Clomipramine Hydrochloride by Zydus Pharmaceuticals
usa Inc
This Multi-event Class II drug recall was voluntarily initiated by Zydus Pharmaceuticals (usa) Inc on October 22, 2025 for the product Clomipramine Hydrochloride. The FDA reported the reason for recall as cgmp deviations. The product was distributed Nationwide and the recall is currently ongoing.
Reported Recall Events
Recall Number: D-0152-2026
cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA acceptable intake limit.
10-22-2025
11-12-2025
N/A
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Zydus Pharmaceuticals (USA) Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide in the US
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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
Recall Number: D-0153-2026
cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA acceptable intake limit.
10-22-2025
11-12-2025
N/A
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Zydus Pharmaceuticals (USA) Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide in the US
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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
Recall Number: D-0154-2026
cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA acceptable intake limit.
10-22-2025
11-12-2025
N/A
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Zydus Pharmaceuticals (USA) Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide in the US
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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
