Chlorpromazine recalls

The FDA has published 25 recalls involving Chlorpromazine since 2025. The latest was reported on 24 Sep 2025. Most were for nitrosamine impurity. Zydus Pharmaceuticals (USA) 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 recalls25since 2025

Last 12 months4reported

Class I00% of total

Ongoing25latest 24 Sep 2025

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 2Jan '25 0 0 3Apr 0 0 0Jul 0 20 0Oct 0 0 0Jan '26 0 0 0Apr 0 0 0Jul 0 0

Severity split

Class I 0 0%Class II 25 100%Class III 0 0%

Why chlorpromazine is recalled

Companies

By year

202525100%

Ongoing chlorpromazine recalls

25 active

Reported	Class	Recall	Company	Reason	Where
24 Sep 2025Drug	CLASS II	chlorproMAZINE Hydrochloride Tablets, USP, 25 mg recalledChlorpromazine Hydrochloride	Amerisource Health Services	Packaging Defects	Nationwide
24 Sep 2025Drug	CLASS II	chlorproMAZINE Hydrochloride Tablets, USP, 100 mg recalledChlorpromazine Hydrochloride	Amerisource Health Services	Packaging Defects	Nationwide
24 Sep 2025Drug	CLASS II	chlorproMAZINE Hydrochloride Tablets, USP, 50 mg, 100 blisterpacks recalledChlorpromazine Hydrochloride	Amerisource Health Services	Packaging Defects	Nationwide
24 Sep 2025Drug	CLASS II	chlorproMAZINE Hydrochloride Tablets, USP, 200 mg recalledChlorpromazine Hydrochloride	Amerisource Health Services	Packaging Defects	Nationwide
17 Sep 2025Drug	CLASS II	Chlorpromazine Hydrochloride Tablets, USP, 10 mg recalledChlorpromazine Hydrochloride	Zydus Pharmaceuticals (USA)	Nitrosamine Impurity	Nationwide
17 Sep 2025Drug	CLASS II	Chlorpromazine Hydrochloride Tablets, USP, 200 mg recalledChlorpromazine Hydrochloride	Zydus Pharmaceuticals (USA)	Nitrosamine Impurity	Nationwide

All chlorpromazine recalls, newest first

25 total

Reported	Class	Recall	Company	Reason	Where
24 Sep 2025Drug	CLASS II	chlorproMAZINE Hydrochloride Tablets, USP, 25 mg recalledChlorpromazine Hydrochloride	Amerisource Health Services	Packaging Defects	Nationwide
24 Sep 2025Drug	CLASS II	chlorproMAZINE Hydrochloride Tablets, USP, 100 mg recalledChlorpromazine Hydrochloride	Amerisource Health Services	Packaging Defects	Nationwide
24 Sep 2025Drug	CLASS II	chlorproMAZINE Hydrochloride Tablets, USP, 50 mg, 100 blisterpacks recalledChlorpromazine Hydrochloride	Amerisource Health Services	Packaging Defects	Nationwide
24 Sep 2025Drug	CLASS II	chlorproMAZINE Hydrochloride Tablets, USP, 200 mg recalledChlorpromazine Hydrochloride	Amerisource Health Services	Packaging Defects	Nationwide
17 Sep 2025Drug	CLASS II	Chlorpromazine Hydrochloride Tablets, USP, 10 mg recalledChlorpromazine Hydrochloride	Zydus Pharmaceuticals (USA)	Nitrosamine Impurity	Nationwide
17 Sep 2025Drug	CLASS II	Chlorpromazine Hydrochloride Tablets, USP, 200 mg recalledChlorpromazine Hydrochloride	Zydus Pharmaceuticals (USA)	Nitrosamine Impurity	Nationwide
17 Sep 2025Drug	CLASS II	Chlorpromazine Hydrochloride Tablets, USP, 100 mg recalledChlorpromazine Hydrochloride	Zydus Pharmaceuticals (USA)	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 (USA)	Nitrosamine Impurity	Nationwide
17 Sep 2025Drug	CLASS II	Chlorpromazine Hydrochloride Tablets, USP, 200 mg recalledChlorpromazine Hydrochloride	Zydus Pharmaceuticals (USA)	Nitrosamine Impurity	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.