Chlorpromazine Hydrochloride recalls

Chlorpromazine Hydrochloride products have been recalled 20 times, most recently on 17 Sep 2025. The recalling company is usually Zydus Pharmaceuticals. The most common reason is nitrosamine impurity.

Total recalls20since 2025

Last 12 months0reported

Class I00% of total

Ongoing20latest 17 Sep 2025

Recalls per month, last 24 months

click a bar for that month

0Nov '24 0 2 0Feb 0 2 0May 0 0 0Aug 16 0 0Nov 0 0 0Feb 0 0 0May 0 0 0Aug 0 0

Severity split

Class I 0 0%Class II 20 100%Class III 0 0%

Why chlorpromazine hydrochloride is recalled

Companies

By year

202520100%

Ongoing chlorpromazine hydrochloride recalls

20 active

Reported	Class	Recall	Company	Reason	Where
17 Sep 2025Drug	CLASS II	Chlorpromazine Hydrochloride Tablets, USP, 10 mg recalledChlorpromazine Hydrochloride	Zydus Pharmaceuticals	Nitrosamine Impurity	Nationwide
17 Sep 2025Drug	CLASS II	Chlorpromazine Hydrochloride Tablets, USP, 200 mg recalledChlorpromazine Hydrochloride	Zydus Pharmaceuticals	Nitrosamine Impurity	Nationwide
17 Sep 2025Drug	CLASS II	Chlorpromazine Hydrochloride Tablets, USP, 100 mg recalledChlorpromazine Hydrochloride	Zydus Pharmaceuticals	Nitrosamine Impurity	Nationwide
17 Sep 2025Drug	CLASS II	chloroproMAZINE Hydrochloride Tablets, USP, 100 mg unit dose recalledChlorpromazine Hydrochloride	AvKARE	Other	Nationwide
17 Sep 2025Drug	CLASS II	Chlorpromazine Hydrochloride Tablets, USP, 50 mg recalledChlorpromazine Hydrochloride	Zydus Pharmaceuticals	Nitrosamine Impurity	Nationwide
17 Sep 2025Drug	CLASS II	Chlorpromazine Hydrochloride Tablets, USP, 200 mg recalledChlorpromazine Hydrochloride	Zydus Pharmaceuticals	Nitrosamine Impurity	Nationwide

All chlorpromazine hydrochloride recalls, newest first

20 total

Reported	Class	Recall	Company	Reason	Where
17 Sep 2025Drug	CLASS II	Chlorpromazine Hydrochloride Tablets, USP, 10 mg recalledChlorpromazine Hydrochloride	Zydus Pharmaceuticals	Nitrosamine Impurity	Nationwide
17 Sep 2025Drug	CLASS II	Chlorpromazine Hydrochloride Tablets, USP, 200 mg recalledChlorpromazine Hydrochloride	Zydus Pharmaceuticals	Nitrosamine Impurity	Nationwide
17 Sep 2025Drug	CLASS II	Chlorpromazine Hydrochloride Tablets, USP, 100 mg recalledChlorpromazine Hydrochloride	Zydus Pharmaceuticals	Nitrosamine Impurity	Nationwide
17 Sep 2025Drug	CLASS II	chloroproMAZINE Hydrochloride Tablets, USP, 100 mg unit dose recalledChlorpromazine Hydrochloride	AvKARE	Other	Nationwide
17 Sep 2025Drug	CLASS II	Chlorpromazine Hydrochloride Tablets, USP, 50 mg recalledChlorpromazine Hydrochloride	Zydus Pharmaceuticals	Nitrosamine Impurity	Nationwide
17 Sep 2025Drug	CLASS II	Chlorpromazine Hydrochloride Tablets, USP, 200 mg recalledChlorpromazine Hydrochloride	Zydus Pharmaceuticals	Nitrosamine Impurity	Nationwide
17 Sep 2025Drug	CLASS II	chloroproMAZINE Hydrochloride Tablets, USP, 50 mg unit dose recalledChlorpromazine Hydrochloride	AvKARE	Other	Nationwide
17 Sep 2025Drug	CLASS II	Chlorpromazine Hydrochloride Tablets, USP, 25 mg recalledChlorpromazine Hydrochloride	Zydus Pharmaceuticals	Nitrosamine Impurity	Nationwide
17 Sep 2025Drug	CLASS II	Chlorpromazine Hydrochloride Tablets, USP, 25 mg recalledChlorpromazine Hydrochloride	Zydus Pharmaceuticals	Nitrosamine Impurity	Nationwide
17 Sep 2025Drug	CLASS II	Chlorpromazine Hydrochloride Tablets, USP, 100 mg recalledChlorpromazine Hydrochloride	Zydus Pharmaceuticals	Nitrosamine Impurity	Nationwide
17 Sep 2025Drug	CLASS II	Chlorpromazine Hydrochloride Tablets, USP, 10 mg recalledChlorpromazine Hydrochloride	Zydus Pharmaceuticals	Nitrosamine Impurity	Nationwide
17 Sep 2025Drug	CLASS II	Chlorpromazine Hydrochloride Tablets, USP, 50 mg recalledChlorpromazine Hydrochloride	Zydus Pharmaceuticals	Nitrosamine Impurity	Nationwide
10 Sep 2025Drug	CLASS II	chlorproMAZINE Hydrochloride Tablets, USP, 50 mg recalledChlorpromazine Hydrochloride	Amneal Pharmaceuticals	Packaging Defects	Nationwide
10 Sep 2025Drug	CLASS II	chlorproMAZINE Hydrochloride Tablets, USP, 25 mg recalledChlorpromazine Hydrochloride	Amneal Pharmaceuticals	Packaging Defects	Nationwide
10 Sep 2025Drug	CLASS II	chlorproMAZINE Hydrochloride Tablets, USP, 100 mg recalledChlorpromazine Hydrochloride	Amneal Pharmaceuticals	Packaging Defects	Nationwide
10 Sep 2025Drug	CLASS II	chlorproMAZINE Hydrochloride Tablets, USP, 200 mg recalledChlorpromazine Hydrochloride	Amneal Pharmaceuticals	Packaging Defects	Nationwide
16 Apr 2025Drug	CLASS II	chlorproMAZINE Hydrochloride Tablets, USP 10 mg recalledChlorpromazine Hydrochloride	Zydus Pharmaceuticals	Nitrosamine Impurity	Nationwide
9 Apr 2025Drug	CLASS II	chlorproMAZINE Hydrochloride Tablets, USP 100 mg recalledChlorpromazine Hydrochloride	Glenmark Pharmaceuticals Inc., USA	Nitrosamine Impurity	Nationwide
1 Jan 2025Drug	CLASS II	chlorproMAZINE Hydrochloride Tablets, USP, 25 mg recalledChlorpromazine Hydrochloride	Glenmark Pharmaceuticals Inc., USA	Nitrosamine Impurity	Nationwide
1 Jan 2025Drug	CLASS II	chlorproMAZINE Hydrochloride Tablets, USP, 10mg recalledChlorpromazine Hydrochloride	Glenmark Pharmaceuticals Inc., USA	Nitrosamine Impurity	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.