Unrated Drug recall · FDA · Published October 22, 2025

Zydus Clomipramine Capsules Recall: Nitrosamine Impurities Risk

Zydus Pharmaceuticals recalls 25mg clomipramine capsules due to nitrosamine impurities exceeding FDA limits. These capsules may pose health risks. Consumers should check product details and contact the manufacturer.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-0152-2026Drug Zydus Pharmaceuticals ›

Recall notice

cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA acceptable intake limit.

Take action

Contact the company

Recalling firmZydus Pharmaceuticals (USA) Inc73 Route 31 N · Pennington, NJ 08534-3601

✎ GovInfoNow plain-language explainer

Zydus Pharmaceuticals is recalling 25mg clomipramine hydrochloride capsules that contain nitrosamine impurities above the FDA's acceptable limit. This could pose health risks to users, especially those taking the medication regularly. Read more at govinfonow.com/recall/31681-zydus-clomipramine-capsules-recall-nitrosamine-impurities-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/31681-zydus-clomipramine-capsules-recall-nitrosamine-impurities-risk · Updated August 17, 2026 · FDA enforcement record: FDA #D-0152-2026

Cite this page

“Zydus Clomipramine Capsules Recall: Nitrosamine Impurities Risk.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/31681-zydus-clomipramine-capsules-recall-nitrosamine-impurities-risk. Based on FDA recall #D-0152-2026 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0152-2026%22&limit=1).

The FDA announced on Oct. 22, 2025, that Zydus Pharmaceuticals (USA) Inc is voluntarily recalling clomipramine hydrochloride capsules, 25 mg, due to cGMP deviations involving nitrosamine impurities above acceptable limits.

How to tell if you have it

Brand: Zydus Pharmaceuticals
Product: clomipramine hydrochloride, Capsules, USP, 25 mg
NDC 16714-849-01 (30-count bottles)
NDC 16714-849-02 (90-count bottles)
NDC 16714-849-03 (100-count bottles)
Lot # E408871, Exp Date: 10/2026
Lot # E405282, Exp Date: 06/2026
Lot # E400386, Exp Date: 12/2025
Lot # E408872, Exp Date: 10/2026
Lot # E405280, Exp Date: 06/2026
Lot # E408873, Exp Date: 10/2026
Lot # E405281, Exp Date: 06/2026
Lot # E400387, Exp Date: 12/2025

The hazard

The recall addresses cGMP deviations where an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), specifically N-Nitroso Desmethyl-Clomipramine, was found above the FDA acceptable intake limit.

Context

GovInfoNow's records show Zydus Pharmaceuticals (USA) Inc has 53 other recalls on record since 2012-03-14. Other recent recalls of similar products include Zydus Mirabegron 25mg Tablets Recall (2026-08-05), Zydus Erythromycin Tablets Recall (2026-04-29), and Zydus Recalls Icosapent Ethyl Capsules Due to Defects (2026-03-09). Other recent recalls of similar products include Asclemed Duloxetine Capsules Recall (2026-05-14), Breckenridge Duloxetine Capsules Recall (2026-04-21), and Appco Pharma Prazosin Capsules Recall (2026-03-27).

How to tell if you have this one

Check for 25mg clomipramine capsules with NDC numbers 16714-849-01 (30-count), 16714-849-02 (90-count), or 16714-849-03 (100-count). The capsules are prescription-only and manufactured by Zydus Lifesciences Ltd.

Brand
Zydus Pharmaceuticals
Category
Drug

FDA recall event · 3 products

All 3 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Ongoing
Distribution
Nationwide in the US
NDC
16714-849-02, 16714-849-01, 16714-849-03, 16714-850-01, 16714-850-03, 16714-850-02, 16714-851-01, 16714-851-03, 16714-851-02

Recall number	Product, codes & lots
D-0152-2026	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; 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
D-0153-2026	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; 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
D-0154-2026	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.; 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

Based on the official FDA remedy

What to do — step by step

Check Product Details
Identify the NDC number on the packaging to confirm if your capsules are part of the recall.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “Nationwide in the US” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA published this recall 21 days after the firm started it.

Oct 22, 2025Firm started the recall
Nov 4, 2025FDA classified it Class II
Nov 12, 2025Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/31681-zydus-clomipramine-capsules-recall-nitrosamine-impurities-risk">Zydus Clomipramine Capsules Recall: Nitrosamine Impurities Risk (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #D-0152-2026 (October 22, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0152-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.