Prescription chlorpromazine tablets recalled due to manufacturing quality defect
Glenmark Pharmaceuticals is recalling chlorpromazine hydrochloride 10mg tablets nationwide due to manufacturing deviations that allowed excess N-nitroso impurity.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II manufacturing defect with impurity exceeding limits. The Severe criterion requires Class II recalls with hospitalization reports, which are not mentioned. A High score reflects manufacturing quality deviation without documented adverse events.
Plain-English summary
Glenmark Pharmaceuticals Inc., USA is recalling chlorpromazine hydrochloride tablets, USP, 10mg in 100-count bottles due to manufacturing quality issues. Approximately 3,888 units were distributed nationwide.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Testing found that N-nitroso-desmethyl chlorpromazine impurity (NNDCI) levels exceeded FDA recommended limits.
Chlorpromazine is a prescription antipsychotic medication used to treat psychiatric conditions. Affected lot numbers are 17230132 (expiration 12/2024) and 17230449 (expiration 01/2025).
Patients taking this medication should contact their healthcare provider or pharmacist. Do not discontinue medication without medical guidance. Return affected bottles to the pharmacy.
The recalled product
- Product
- CHLORPROMAZINE HYDROCHLORIDE (CHLORPROMAZINE HYDROCHLORIDE)
- Brand
- CHLORPROMAZINE HYDROCHLORIDE
- Manufacturer
- Glenmark Pharmaceuticals Inc., USA
- Category
- Drug — Antipsychotic
- Affected units
- 3,888
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 (4)
- Lot#: 17230132
- Exp 12/2024
- 17230449
- Exp 01/2025
UPCs (4)
- 0368462862018
- 0368462864012
- 0368462863015
- 0368462861011
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Glenmark Pharmaceuticals Inc., USA under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
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