Prescription Antipsychotic Drug Recalled for Manufacturing Impurity
Glenmark Pharmaceuticals is recalling Chlorpromazine Hydrochloride Tablets due to a manufacturing quality deviation involving an impurity above recommended limits.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II recall involving a manufacturing quality deviation with an impurity above recommended limits. No illnesses, injuries, or hospitalizations are reported in the source text, placing this in the Moderate category per the rubric.
Plain-English summary
Glenmark Pharmaceuticals Inc., USA is recalling Chlorpromazine Hydrochloride Tablets, USP 100 mg. The recall affects 8,160 bottles distributed nationwide in the USA and Puerto Rico.
The recall is due to a Current Good Manufacturing Practice (CGMP) deviation. Testing identified N-Nitroso-Desmethyl Chlorpromazine impurity present above the recommended interim limit in the affected product.
The recalled product is identified by lot numbers 17232222 and 17232237, which expire on 10/31/2025. The product is manufactured for Glenmark Pharmaceuticals Inc., USA (Mahwah, NJ) and produced in India. Patients taking this medication should consult their pharmacist or prescribing physician regarding next steps.
The recalled product
- Product
- CHLORPROMAZINE HYDROCHLORIDE (CHLORPROMAZINE HYDROCHLORIDE)
- Brand
- CHLORPROMAZINE HYDROCHLORIDE
- Manufacturer
- Glenmark Pharmaceuticals Inc., USA
- Hazard
- Affected units
- 8,160
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#s: 17232222 and 17232237
- Exp 10/31/2025
UPCs (4)
- 0368462862018
- 0368462864012
- 0368462863015
- 0368462861011
Distribution
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