Fluphenazine Hydrochloride Tablets 2.5mg Recalled by Glenmark Pharmaceuticals
Glenmark Pharmaceuticals Inc., USA is voluntarily recalling Fluphenazine Hydrochloride Tablets 2.5mg nationwide due to Current Good Manufacturing Practice (CGMP) deviations. The affected lot is 17232214 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 initiated voluntarily by the firm due to CGMP deviations. The source text contains no reports of illness, injury, or adverse health consequences. Class II recalls with theoretical manufacturing defects and no reported harm are classified as Moderate under the rubric.
Plain-English summary
Glenmark Pharmaceuticals Inc., USA is voluntarily recalling Fluphenazine Hydrochloride Tablets 2.5mg (100-count bottles) distributed nationwide. The recall was initiated on March 13, 2025, and classified by the FDA as Class II on April 8, 2025.
The product is being recalled due to Current Good Manufacturing Practice (CGMP) deviations. The affected lot is Lot #17232214 with an expiration date of September 2025. The product is manufactured by Glenmark Pharmaceuticals Limited in Pithampur, Madhya Pradesh, India, and distributed by Glenmark Pharmaceuticals Inc., USA in Mahwah, NJ. The NDC number is 68462-336-01.
Consumers who have this medication should consult their healthcare provider or pharmacist about their prescription. Do not stop taking the medication without medical guidance, as fluphenazine is a prescription antipsychotic. Healthcare providers and pharmacists should check their inventory and quarantine affected product.
The recalled product
- Product
- FLUPHENAZINE HYDROCHLORIDE (FLUPHENAZINE HYDROCHLORIDE)
- Brand
- FLUPHENAZINE HYDROCHLORIDE
- Manufacturer
- Glenmark Pharmaceuticals Inc., USA
- Hazard
- cgmp-deviation
- manufacturing-defect
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 # 17232214
- exp. date Sep-25
UPCs (4)
- 0368462338018
- 0368462337011
- 0368462914014
- 0368462336014
Distribution
Distributed nationwide across the United States.
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