Fluphenazine Hydrochloride Drug Recall Due to Manufacturing Process Deviations
Glenmark Pharmaceuticals is recalling Fluphenazine Hydrochloride Tablets 2.5mg nationwide due to manufacturing deviations. The company initiated this voluntary Class II recall after determining that production did not meet FDA standards.
What this means for you
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 due to manufacturing process deviations in pharmaceutical production. No illnesses or injuries have been reported. Per the severity rubric, risk-of-harm products where injury has not yet been reported warrant a High severity rating.
Plain-English summary
Glenmark Pharmaceuticals Inc. USA is recalling Fluphenazine Hydrochloride Tablets 2.5mg distributed nationwide. The affected lot is number 17232214, expiring September 2025. Glenmark voluntarily initiated the recall after identifying Current Good Manufacturing Practice (CGMP) deviations in the manufacturing process.
CGMP deviations indicate that tablet production did not meet federal manufacturing standards for quality control. On March 13, 2025, Glenmark notified customers and initiated retrieval of affected medication from the market. No illnesses or injuries have been reported in association with this product.
Patients taking this prescription medication should verify whether their supply matches the recalled lot number by checking the medication container. Those with the recalled lot should contact their healthcare provider or pharmacist for guidance on next steps. Unused medication should be returned to the pharmacy.
The recalled product
- Product
- FLUPHENAZINE HYDROCHLORIDE (FLUPHENAZINE HYDROCHLORIDE)
- Brand
- FLUPHENAZINE HYDROCHLORIDE
- Manufacturer
- Glenmark Pharmaceuticals Inc., USA
- Category
- Drug
- Hazard
- cgmp-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 # 17232214
- exp. date Sep-25
UPCs (4)
- 0368462338018
- 0368462337011
- 0368462914014
- 0368462336014
Distribution
Distributed nationwide across the United States.
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