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.
What this means for you
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
Related recalls
Same brand · CHLORPROMAZINE HYDROCHLORIDE
- ModerateChlorpromazine 25 mg blisterpacks recalled over micro-organism on packaging coil
FDA (Drugs) · 2025-09-24
- ModeratePackaged chlorpromazine cartons recalled over micro-organism on packaging coil
FDA (Drugs) · 2025-09-24
- ModerateChlorpromazine 50 mg blisterpacks recalled over micro-organism on packaging coil
FDA (Drugs) · 2025-09-24
- ModerateChlorpromazine 100 mg cartons recalled over micro-organism on packaging coil
FDA (Drugs) · 2025-09-24
- HighNorthstar chlorpromazine 50 mg tablets recalled over nitrosamine impurity level
FDA (Drugs) · 2025-09-17
Same manufacturer · Glenmark Pharmaceuticals Inc., USA
See all →- ModerateAzelaic Acid Gel 15% Recalled Over Grainy, Gritty, or Sandy Texture
FDA (Drugs) · 2026-08-05
- ModerateAlyacen 7/7/7 birth control tablets failed total impurities specification
FDA (Drugs) · 2026-06-24
- ModerateOndansetron tablets recalled because blister packs are not fully sealed
FDA (Drugs) · 2026-01-07
- CriticalFrozen chopped methi recalled after testing positive for Salmonella
FDA (Drugs) · 2025-12-17
- ModerateBisoprolol and hydrochlorothiazide tablets recalled over traces of another drug
FDA (Drugs) · 2025-12-10
Same hazard · impurity
See all →- ModerateHikma Recalls Ramipril Capsules Due to Process Impurity
FDA (Drugs) · 2026-09-02
- ModerateMedline Remedy Specialized Silicone Cream Recalled for Elevated Formaldehyde Levels
FDA (Drugs) · 2026-07-15
- SevereCinacalcet Hydrochloride Tablets Recalled for Elevated Impurity Levels
FDA (Drugs) · 2026-07-08
- HighDuloxetine 60mg delayed-release capsules exceed nitrosamine impurity interim limit
FDA (Drugs) · 2026-06-17
- HighDuloxetine 30mg delayed-release capsules exceed nitrosamine impurity interim limit
FDA (Drugs) · 2026-06-17