Clomipramine recalls

The FDA has published 8 recalls involving Clomipramine since 2014. The latest was reported on 12 Nov 2025. Most were for potency & assay. Zydus Pharmaceuticals has the most recalls in this group. Recalls usually affect specific lots, not every bottle on the market. Check the lot number on each recall page before acting.

Total recalls8since 2014

Last 12 months3reported

Class I00% of total

Ongoing3latest 12 Nov 2025

Recalls per month, last 24 months

click a bar for that month

0Nov '24 0 0 0Feb 0 1 0May 0 1 0Aug 0 0 3Nov 0 0 0Feb 0 0 0May 0 0 0Aug 0 0

Severity split

Class I 0 0%Class II 7 88%Class III 1 13%

Why clomipramine is recalled

Companies

By year

2025563%
2022113%
2020113%
2014113%

Ongoing clomipramine recalls

3 active

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

All clomipramine recalls, newest first

8 total

Reported	Class	Recall	Company	Reason	Where
12 Nov 2025Drug	CLASS II	clomiPRAMINE Hydrochloride, Capsules, USP, 75 mg recalledClomipramine Hydrochloride	Zydus Pharmaceuticals	Nitrosamine Impurity	Nationwide
12 Nov 2025Drug	CLASS II	clomiPRAMINE Hydrochloride, Capsules, USP, 50 mg recalledClomipramine Hydrochloride	Zydus Pharmaceuticals	Nitrosamine Impurity	Nationwide
12 Nov 2025Drug	CLASS II	clomiPRAMINE Hydrochloride, Capsules, USP, 25 mg recalledClomipramine Hydrochloride	Zydus Pharmaceuticals	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
2 Dec 2020Drug	CLASS II	clomiPRAMINE Hydrochloride Capsules USP, 50 mg recalled	Jubilant Cadista Pharmaceuticals	Other	Nationwide
22 Jan 2014Drug	CLASS II	clomiPRAMINE HCl Capsule, 50 mg recalled by Aidapak Services	Aidapak Services	Labeling Errors	4 states

Should you stop taking Clomipramine?

Not on your own. Most recalls affect specific lots from one manufacturer, and stopping a prescription suddenly can be riskier than the defect. Check your lot number and NDC against the recall, then call the pharmacy that dispensed it for a replacement.