Clomipramine Hydrochloride recalls

Clomipramine Hydrochloride products have been recalled 6 times, most recently on 12 Nov 2025. The recalling company is usually Zydus Pharmaceuticals (USA). The most common reason is nitrosamine impurity.

Total recalls6since 2022

Last 12 months3reported

Class I00% of total

Ongoing3latest 12 Nov 2025

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 0 0 1Apr 0 0 1Jul 0 0 0Oct 3 0 0Jan '26 0 0 0Apr 0 0 0Jul 0 0

Severity split

Class I 0 0%Class II 5 83%Class III 1 17%

Why clomipramine hydrochloride is recalled

Nitrosamine Impurity350%
Potency & Assay350%

Companies

By year

2025583%
2022117%

Ongoing clomipramine hydrochloride recalls

3 active

Reported	Class	Recall	Company	Reason	Where
12 Nov 2025Drug	CLASS II	clomiPRAMINE Hydrochloride, Capsules, USP, 75 mg recalledClomipramine Hydrochloride	Zydus Pharmaceuticals (USA)	Nitrosamine Impurity	Nationwide
12 Nov 2025Drug	CLASS II	clomiPRAMINE Hydrochloride, Capsules, USP, 50 mg recalledClomipramine Hydrochloride	Zydus Pharmaceuticals (USA)	Nitrosamine Impurity	Nationwide
12 Nov 2025Drug	CLASS II	clomiPRAMINE Hydrochloride, Capsules, USP, 25 mg recalledClomipramine Hydrochloride	Zydus Pharmaceuticals (USA)	Nitrosamine Impurity	Nationwide

All clomipramine hydrochloride recalls, newest first

6 total

Reported	Class	Recall	Company	Reason	Where
12 Nov 2025Drug	CLASS II	clomiPRAMINE Hydrochloride, Capsules, USP, 75 mg recalledClomipramine Hydrochloride	Zydus Pharmaceuticals (USA)	Nitrosamine Impurity	Nationwide
12 Nov 2025Drug	CLASS II	clomiPRAMINE Hydrochloride, Capsules, USP, 50 mg recalledClomipramine Hydrochloride	Zydus Pharmaceuticals (USA)	Nitrosamine Impurity	Nationwide
12 Nov 2025Drug	CLASS II	clomiPRAMINE Hydrochloride, Capsules, USP, 25 mg recalledClomipramine Hydrochloride	Zydus Pharmaceuticals (USA)	Nitrosamine Impurity	Nationwide
30 Jul 2025Drug	CLASS II	clomiPRAMINE Hydrochloride Capsules USP 25 mg recalledClomipramine Hydrochloride	Lupin Pharmaceuticals	Potency & Assay	Nationwide
30 Apr 2025Drug	CLASS II	clomiPRAMINE hydrochloride Capsules USP, 25 mg recalledClomipramine Hydrochloride	Lupin Pharmaceuticals	Potency & Assay	Nationwide
5 Oct 2022Drug	CLASS III	ClomiPRAMINE Hydrochloride Capsules, USP 25mg recalled by Leading PharmaClomipramine Hydrochloride	Leading Pharma	Potency & Assay	Nationwide

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.