The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-0160-2025·Announced 2025-01-01

Chlorpromazine Hydrochloride tablets recalled for manufacturing impurity excess

Glenmark Pharmaceuticals is recalling Chlorpromazine Hydrochloride tablets due to manufacturing deviations that resulted in an impurity exceeding FDA limits. The affected lot (17230133, expiring 12/31/2024) was 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 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: This is an FDA Class II recall initiated due to manufacturing deviations resulting in impurity levels exceeding FDA limits. No illnesses or injuries have been reported. Per the rubric, this constitutes a 'risk-of-harm product where injury has not yet been reported,' warranting a score of 3.

Plain-English summary

Glenmark Pharmaceuticals Inc., USA is recalling Chlorpromazine Hydrochloride Tablets, USP, 25 mg in 100-count bottles. This recall affects lot number 17230133, which expires 12/31/2024, and was distributed nationwide.

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Testing found that N-Nitroso-Desmethyl Chlorpromazine (NNDCI) impurity exceeded the FDA's recommended limit.

Patients or healthcare providers who may have received medication from this lot should verify the lot number with their pharmacy. Those with questions should contact their pharmacist or healthcare provider.

For more information about this recall, contact Glenmark Pharmaceuticals Inc. or visit the FDA's drug recall website.

The recalled product

Product
CHLORPROMAZINE HYDROCHLORIDE (CHLORPROMAZINE HYDROCHLORIDE)
Brand
CHLORPROMAZINE HYDROCHLORIDE
Manufacturer
Glenmark Pharmaceuticals Inc., USA
Category
Drug
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#: 17230133
  • Exp 12/31/2024

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 →

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