Fluphenazine Hydrochloride Tablets Recalled for CGMP Deviations
Glenmark Pharmaceuticals Inc., USA is voluntarily recalling Fluphenazine Hydrochloride Tablets, 10mg due to Current Good Manufacturing Practice (CGMP) deviations. The recall affects one lot 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 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: This is an FDA Class II recall initiated voluntarily by the firm for CGMP deviations. The source text does not report any illnesses, hospitalizations, or injuries associated with this manufacturing issue, making it a precautionary recall.
Plain-English summary
Glenmark Pharmaceuticals Inc., USA is voluntarily recalling Fluphenazine Hydrochloride Tablets, 10mg, 100-Count Bottles (NDC# 68462-338-01, among others) due to Current Good Manufacturing Practice (CGMP) deviations discovered during manufacturing.
The affected product is Lot #17232206 with an expiration date of September 2025, manufactured by Glenmark Pharmaceuticals Limited in Pithampur, Madhya Pradesh, India, and distributed nationwide in the United States.
Patients currently taking this medication should consult their healthcare provider or pharmacist before taking any action. The firm initiated this recall on March 13, 2025, and it remains ongoing. Healthcare providers and patients should verify lot numbers on their medication bottles to determine if they have affected product.
The recalled product
- Product
- FLUPHENAZINE HYDROCHLORIDE (FLUPHENAZINE HYDROCHLORIDE)
- Brand
- FLUPHENAZINE HYDROCHLORIDE
- Manufacturer
- Glenmark Pharmaceuticals Inc., USA
- Category
- Drug — Prescription Tablet
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 # 17232206
- exp. date Sep-25
UPCs (4)
- 0368462338018
- 0368462337011
- 0368462914014
- 0368462336014
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 39 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.
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