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.
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 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.
See all 39 products in this recall →Related recalls
Same brand · FLUPHENAZINE HYDROCHLORIDE
- ModerateFluphenazine Hydrochloride Tablets 2.5mg Recalled by Glenmark Pharmaceuticals
FDA (Drugs) · 2025-04-16
Same manufacturer · Glenmark Pharmaceuticals Inc., USA
See all →- ModerateAzelaic Acid Gel 15% Recalled Over Grainy, Gritty, or Sandy Texture
FDA (Drugs) · 2026-08-05
- ModerateAlyacen 7/7/7 birth control tablets failed total impurities specification
FDA (Drugs) · 2026-06-24
- ModerateOndansetron tablets recalled because blister packs are not fully sealed
FDA (Drugs) · 2026-01-07
- CriticalFrozen chopped methi recalled after testing positive for Salmonella
FDA (Drugs) · 2025-12-17
- ModerateBisoprolol and hydrochlorothiazide tablets recalled over traces of another drug
FDA (Drugs) · 2025-12-10
Same hazard · cgmp deviation
See all →- HighBaxter Recalls MYXREDLIN Insulin Due to Manufacturing Deviations
FDA (Drugs) · 2026-09-09
- ModerateLexia LLC Recalls Broadway Joe's Pain Cream Due to CGMP Deviations
FDA (Drugs) · 2026-09-09
- SevereBaxter Recalls Daptomycin Injection Due to Manufacturing Deviations
FDA (Drugs) · 2026-09-09
- HighBaxter Recalls Clindamycin Injection Due to Manufacturing Deviations
FDA (Drugs) · 2026-09-09
- SevereBaxter Recalls Clindamycin Injection Due to Manufacturing Deviations
FDA (Drugs) · 2026-09-09