Fluphenazine Hydrochloride recalls

Fluphenazine Hydrochloride products have been recalled 3 times, most recently on 16 Sep 2026. The recalling company is usually Glenmark Pharmaceuticals Inc., USA. The most common reason is manufacturing (cgmp) deviations.

Total recalls3since 2025

Last 12 months1reported

Class I00% of total

Ongoing3latest 16 Sep 2026

Recalls per month, last 24 months

click a bar for that month

0Nov '24 0 0 0Feb 0 2 0May 0 0 0Aug 0 0 0Nov 0 0 0Feb 0 0 0May 0 0 0Aug 1 0

Severity split

Class I 0 0%Class II 2 67%Class III 1 33%

Why fluphenazine hydrochloride is recalled

Manufacturing (CGMP) Deviations267%
Potency & Assay133%

Companies

Glenmark Pharmaceuticals Inc., USA267%
Ajanta Pharma USA133%

By year

2026133%
2025267%

Ongoing fluphenazine hydrochloride recalls

3 active

Reported	Class	Recall	Company	Reason	Where
16 Sep 2026Drug	CLASS III	Fluphenazine Hydrochloride Tablets, USP, 1mg recalledFluphenazine Hydrochloride	Ajanta Pharma USA	Potency & Assay	Nationwide
16 Apr 2025Drug	CLASS II	Fluphenazine Hydrochloride Tablets 2.5mg recalledFluphenazine Hydrochloride	Glenmark Pharmaceuticals Inc., USA	Manufacturing (CGMP) Deviations	Nationwide
16 Apr 2025Drug	CLASS II	Fluphenazine Hydrochloride Tablets, 10mg recalledFluphenazine Hydrochloride	Glenmark Pharmaceuticals Inc., USA	Manufacturing (CGMP) Deviations	Nationwide

All fluphenazine hydrochloride recalls, newest first

3 total

Reported	Class	Recall	Company	Reason	Where
16 Sep 2026Drug	CLASS III	Fluphenazine Hydrochloride Tablets, USP, 1mg recalledFluphenazine Hydrochloride	Ajanta Pharma USA	Potency & Assay	Nationwide
16 Apr 2025Drug	CLASS II	Fluphenazine Hydrochloride Tablets 2.5mg recalledFluphenazine Hydrochloride	Glenmark Pharmaceuticals Inc., USA	Manufacturing (CGMP) Deviations	Nationwide
16 Apr 2025Drug	CLASS II	Fluphenazine Hydrochloride Tablets, 10mg recalledFluphenazine Hydrochloride	Glenmark Pharmaceuticals Inc., USA	Manufacturing (CGMP) Deviations	Nationwide

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.