Fluphenazine Hydrochloride Tablets Recalled for Manufacturing Deviations
Glenmark Pharmaceuticals is voluntarily recalling Fluphenazine Hydrochloride Tablets due to manufacturing practice deviations. Affected lot is 17232206 with expiration date September 2025.
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: This is an FDA Class II recall for CGMP deviations with no reported illnesses, injuries, or specified health hazards. It is a voluntary firm-initiated precautionary recall, fitting the Moderate category per the rubric.
Plain-English summary
Glenmark Pharmaceuticals Inc., USA is voluntarily recalling Fluphenazine Hydrochloride Tablets, 10mg, in 100-count bottles due to Current Good Manufacturing Practice (CGMP) deviations. The affected lot is number 17232206 with an expiration date of September 2025.
The tablets are distributed nationwide. Consumers who have this prescription medication should contact their pharmacist or healthcare provider for guidance.
The recall was initiated by the firm on March 13, 2025. The FDA classified this as a Class II recall on April 8, 2025. CGMP deviations relate to manufacturing and quality control procedures.
The recalled product
- Product
- FLUPHENAZINE HYDROCHLORIDE (FLUPHENAZINE HYDROCHLORIDE)
- Brand
- FLUPHENAZINE HYDROCHLORIDE
- Manufacturer
- Glenmark Pharmaceuticals Inc., USA
- Category
- Drug
- Hazard
- manufacturing-deviation
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.
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