Class II · Moderate risk
chlorproMAZINE Hydrochloride Tablets
CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit.
Is Chlorpromazine recalled?
Yes — there is an active recall. 29 ongoing FDA recalls mention Chlorpromazine (33 total). Check the affected lots below.
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
chlorproMAZINE Hydrochloride Tablets
CGMP Deviations: N-Nitroso-Desmethyl Chlorpromazine impurity (NNDCI) were found to be failing per current FDA recommended limit.
Class II · Moderate risk
chlorproMAZINE Hydrochloride Tablets
CGMP Deviations: N-Nitroso-Desmethyl Chlorpromazine impurity (NNDCI) were found to be failing per current FDA recommended limit.
Class II · Moderate risk
ChlorproMAZINE HCL INJ
Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination and lack of product specific process validations that can result in a lack of sterility assurance.
Class II · Moderate risk
Chlorpromazine HCl active pharmaceutical ingredient packaged in…
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Class II · Moderate risk
chlorproMAZINE HCl
Labeling: Label Mixup: chlorproMAZINE HCl, Tablet, 100 mg may have potentially been mislabeled as one of the following drugs: ACYCLOVIR, Tablet, 800 mg, NDC 00093894701, Pedigree: AD70629_1, EXP: 5/29/2014; TRIMETHOBENZAMIDE HCL, Capsule, 300 mg, NDC 53489037601, Pedigree: AD70625_1, EXP: 5/29/2014.
Class II · Moderate risk
chlorproMAZINE HCl
Labeling: Label Mixup: chlorproMAZINE HCl, Tablet, 50 mg may have potentially been mislabeled as the following drug: ACAMPROSATE CALCIUM DR, Tablet, 333 mg, NDC 00456333001, Pedigree: AD32973_1, EXP: 5/9/2014.
Class II · Moderate risk
Chlorpromazine HCL 100 mg/ml Injection
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
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