CLASS II ONGOING Drug recall · Reported 12 Nov 2025 · FDA Enforcement Report
clomiPRAMINE Hydrochloride, Capsules, USP, 25 mg recalled
Zydus Pharmaceuticals is recalling clomiPRAMINE Hydrochloride, Capsules, USP, 25 mg, distributed nationwide in the US. The recall was initiated on 22 Oct 2025 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0152-2026
- FDA event ID
- 97856
- Recalling firm
- Zydus Pharmaceuticals, Pennington, NJ
- Manufacturer
- Northstar Rx LLC.
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 22 Oct 2025
- FDA classified
- 4 Nov 2025
- Reported
- 12 Nov 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Nitrosamine Impurity
Timeline
| 22 Oct 2025 | Recall initiated by company | |
| 4 Nov 2025 | Classified by FDA | +13 days |
| 12 Nov 2025 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA acceptable intake limit.
Nitrosamines are impurities that can form during drug manufacturing or storage. Above the FDA acceptable intake limit, long-term exposure may raise cancer risk. The FDA advises patients to keep taking the medicine until they have a replacement.
Product as listed by the FDA
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
Where it was distributed
Nationwide in the US
Questions about this recall
Why was it recalled?
cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA acceptable intake limit.
Which lots are affected?
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
Where was it sold?
Nationwide in the US
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
2 other products · FDA event 97856| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | clomiPRAMINE Hydrochloride, Capsules, USP, 50 mg recalledClomipramine Hydrochloride | Zydus Pharmaceuticals | Nitrosamine Impurity | Nationwide | |
| CLASS II | clomiPRAMINE Hydrochloride, Capsules, USP, 75 mg recalledClomipramine Hydrochloride | Zydus Pharmaceuticals | Nitrosamine Impurity | Nationwide |
More recalls from Zydus Pharmaceuticals
All 54| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Mirabegron Extended-Release Tablets, 25 mg recalledMirabegron | Zydus Pharmaceuticals | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Erythromycin Tablets, USP, 250 mg recalledErythromycin | Zydus Pharmaceuticals | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Erythromycin Tablets, USP, 500 mg recalledErythromycin | Zydus Pharmaceuticals | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Icosapent Ethyl Capsules recalled by Zydus Pharmaceuticals (USA)Icosapent Ethyl | Zydus Pharmaceuticals | Other | Nationwide |
| Drug | CLASS II | Icosapent Ethyl capsules recalled by Zydus Pharmaceuticals (USA) | Zydus Pharmaceuticals | Potency & Assay | Nationwide |
Other Clomipramine recalls
All 8| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | clomiPRAMINE Hydrochloride, Capsules, USP, 75 mg recalledClomipramine Hydrochloride | Zydus Pharmaceuticals | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | clomiPRAMINE Hydrochloride, Capsules, USP, 50 mg recalledClomipramine Hydrochloride | Zydus Pharmaceuticals | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | clomiPRAMINE Hydrochloride Capsules USP 25 mg recalledClomipramine Hydrochloride | Lupin Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | clomiPRAMINE hydrochloride Capsules USP, 25 mg recalledClomipramine Hydrochloride | Lupin Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS III | ClomiPRAMINE Hydrochloride Capsules, USP 25mg recalled by Leading PharmaClomipramine Hydrochloride | Leading Pharma | Potency & Assay | Nationwide |