Chlorpromazine recalls

The FDA has published 28 recalls involving Chlorpromazine since 2013. The latest was reported on 24 Sep 2025. Most were for nitrosamine impurity. 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 recalls28since 2013

Last 12 months0reported

Class I00% of total

Ongoing26latest 24 Sep 2025

Recalls per month, last 24 months

click a bar for that month

0Nov '24 0 2 0Feb 0 3 0May 0 0 0Aug 20 0 0Nov 0 0 0Feb 0 0 0May 0 0 0Aug 0 0

Severity split

Class I 0 0%Class II 28 100%Class III 0 0%

Why chlorpromazine is recalled

Companies

By year

20252589%
201427%
201314%

Ongoing chlorpromazine recalls

26 active

Reported	Class	Recall	Company	Reason	Where
24 Sep 2025Drug	CLASS II	chlorproMAZINE Hydrochloride Tablets, USP, 25 mg recalled	Amerisource Health Services	Packaging Defects	Nationwide
24 Sep 2025Drug	CLASS II	chlorproMAZINE Hydrochloride Tablets, USP, 100 mg recalled	Amerisource Health Services	Packaging Defects	Nationwide
24 Sep 2025Drug	CLASS II	chlorproMAZINE Hydrochloride Tablets, USP, 50 mg, 100 blisterpacks recalled	Amerisource Health Services	Packaging Defects	Nationwide
24 Sep 2025Drug	CLASS II	chlorproMAZINE Hydrochloride Tablets, USP, 200 mg recalled	Amerisource Health Services	Packaging Defects	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, 200 mg recalledChlorpromazine Hydrochloride	Zydus Pharmaceuticals	Nitrosamine Impurity	Nationwide

All chlorpromazine recalls, newest first

28 total

Reported	Class	Recall	Company	Reason	Where
24 Sep 2025Drug	CLASS II	chlorproMAZINE Hydrochloride Tablets, USP, 25 mg recalled	Amerisource Health Services	Packaging Defects	Nationwide
24 Sep 2025Drug	CLASS II	chlorproMAZINE Hydrochloride Tablets, USP, 100 mg recalled	Amerisource Health Services	Packaging Defects	Nationwide
24 Sep 2025Drug	CLASS II	chlorproMAZINE Hydrochloride Tablets, USP, 50 mg, 100 blisterpacks recalled	Amerisource Health Services	Packaging Defects	Nationwide
24 Sep 2025Drug	CLASS II	chlorproMAZINE Hydrochloride Tablets, USP, 200 mg recalled	Amerisource Health Services	Packaging Defects	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, 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
23 Apr 2025Drug	CLASS II	ChlorproMAZINE Hydrochloride Tablets, USP, 10 mg recalled	The Harvard Drug Group	Nitrosamine Impurity	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
29 Jan 2014Drug	CLASS II	chlorproMAZINE HCl, Tablet, 50 mg recalled by Aidapak Services	Aidapak Services	Labeling Errors	4 states
29 Jan 2014Drug	CLASS II	chlorproMAZINE HCl, Tablet, 100 mg recalled by Aidapak Services	Aidapak Services	Labeling Errors	4 states
17 Jul 2013Drug	CLASS II	Chlorpromazine HCL 100 mg/ml Injection recalled by Lowlite Investments	Lowlite Investments	Sterility	Nationwide

Should you stop taking Chlorpromazine?

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.