Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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Is Chlorpromazine recalled?

Yes — there is an active recall. 29 ongoing FDA recalls mention Chlorpromazine (33 total). Check the affected lots below.

Most common reason: Nitrosamine impurity (20 of these recalls)

Recalls are matched by product description. A recall usually affects specific lots, not every package of Chlorpromazine. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.

Chlorpromazine recalls on record

none so far in 2026; 33 on record, newest first
Class II · Moderate risk

Major ChlorproMAZINE Hydrochloride Tablets

CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit

Ongoing Nitrosamine impurity The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories NDC 0904-7133-61 D-0013-2026
Class II · Moderate risk

Major ChlorproMAZINE Hydrochloride Tablets

CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit

Ongoing Nitrosamine impurity The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories NDC 0904-7132-61 D-0012-2026
Class II · Moderate risk

Major ChlorproMAZINE Hydrochloride Tablets

CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit

Ongoing Nitrosamine impurity The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories NDC 0904-7131-61 D-0011-2026
Class II · Moderate risk

Major ChlorproMAZINE Hydrochloride Tablets

CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit

Ongoing Nitrosamine impurity The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories NDC 0904-7130-61 D-0010-2026
Class II · Moderate risk

Major ChlorproMAZINE Hydrochloride Tablets

CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit

Ongoing Nitrosamine impurity The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories NDC 0904-7130-06 D-0009-2026
Class II · Moderate risk

chlorproMAZINE Hydrochloride Tablets

Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging at the manufacturing site, was detected with presence of a micro-organism. No micro-organism was detected on any tablets.

Ongoing Particulate / foreign matter Amerisource Health Services LLC D-0650-2025
Class II · Moderate risk

chlorproMAZINE Hydrochloride Tablets

Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging at the manufacturing site, was detected with presence of a micro-organism. No micro-organism was detected on any tablets.

Ongoing Particulate / foreign matter Amerisource Health Services LLC D-0649-2025
Class II · Moderate risk

chlorproMAZINE Hydrochloride Tablets

Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging at the manufacturing site, was detected with presence of a micro-organism. No micro-organism was detected on any tablets.

Ongoing Particulate / foreign matter Amerisource Health Services LLC D-0648-2025
Class II · Moderate risk

chlorproMAZINE Hydrochloride Tablets

Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging at the manufacturing site, was detected with presence of a micro-organism. No micro-organism was detected on any tablets.

Ongoing Particulate / foreign matter Amerisource Health Services LLC D-0647-2025
Class II · Moderate risk

chlorproMAZINE Hydrochloride Tablets

Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.

Ongoing Particulate / foreign matter Amneal Pharmaceuticals, LLC NDC 69238-1062-1 D-0619-2025
Class II · Moderate risk

chlorproMAZINE Hydrochloride Tablets

Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.

Ongoing Particulate / foreign matter Amneal Pharmaceuticals, LLC NDC 69238-1060-1 D-0618-2025
Class II · Moderate risk

chlorproMAZINE Hydrochloride Tablets

Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.

Ongoing Particulate / foreign matter Amneal Pharmaceuticals, LLC NDC 69238-1058-1 D-0617-2025
Class II · Moderate risk

chlorproMAZINE Hydrochloride Tablets

Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.

Ongoing Particulate / foreign matter Amneal Pharmaceuticals, LLC NDC 69238-1056-1 D-0616-2025
Class II · Moderate risk

ChlorproMAZINE Hydrochloride Tablets

CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit

Ongoing Nitrosamine impurity The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories NDC 0904-7129-61 D-0366-2025