Chlorpromazine Hydrochloride Tablets Recalled Due to Impurity
Zydus Pharmaceuticals is recalling chlorpromazine hydrochloride 10 mg tablets due to the presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit. The recall affects 3,144 bottles distributed nationwide.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class II recall involving a prescription drug with a manufacturing deviation that introduces an impurity (N-Nitroso-Desmethyl Chlorpromazine), which triggers Severe classification. The source does not report illnesses or hospitalizations, but the CGMP deviation and impurity presence in a systemic prescription drug warrants a score of 4.
Plain-English summary
Zydus Pharmaceuticals (USA) Inc. is recalling chlorpromazine hydrochloride tablets, USP 10 mg (NDC 70710-1129-1), manufactured by Zydus Lifesciences Ltd. in Baddi, India. The recall was initiated due to the presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit, which constitutes a current Good Manufacturing Practice (CGMP) deviation.
A total of 3,144 bottles with lot number Z400069 and expiration date 12/31/2025 have been affected. The product was distributed nationwide to the following states: MS, AL, TN, VT, OH, ND, MN, WI, SC, AR, FL, IN, LA, NJ, AZ, TX, KY, and PA.
Consumers who have this medication should contact their healthcare provider or pharmacist for guidance. Patients should not discontinue use of the medication without medical supervision, as chlorpromazine is a prescribed antipsychotic medication. Healthcare providers and pharmacists are asked to recall this lot and quarantine any affected inventory.
The recalled product
- Product
- CHLORPROMAZINE HYDROCHLORIDE (CHLORPROMAZINE HYDROCHLORIDE)
- Brand
- CHLORPROMAZINE HYDROCHLORIDE
- Manufacturer
- Zydus Pharmaceuticals (USA) Inc
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #: Z400069
- Exp.: 12/31/2025
UPCs (3)
- 0370710112912
- 0370710113216
- 0370710113018
Distribution
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