Fluphenazine recalls

The FDA has published 4 recalls involving Fluphenazine since 2013. The latest was reported on 16 Sep 2026. Most were for manufacturing (cgmp) deviations. Glenmark Pharmaceuticals Inc., USA has the most recalls in this group. Recalls usually affect specific lots, not every bottle on the market. Check the lot number on each recall page before acting.

Total recalls4since 2013

Last 12 months1reported

Class I00% of total

Ongoing4latest 16 Sep 2026

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 0 0 2Apr 0 0 0Jul 0 0 0Oct 0 0 0Jan '26 0 0 0Apr 0 0 0Jul 0 1

Severity split

Class I 0 0%Class II 3 75%Class III 1 25%

Why fluphenazine is recalled

Companies

By year

2026125%
2025250%
2013125%

Ongoing fluphenazine recalls

4 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
17 Jul 2013Drug	CLASS II	Fluphenazine 25 mg/ml Injection recalled by Lowlite Investments	Lowlite Investments	Sterility	Nationwide

All fluphenazine recalls, newest first

4 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
17 Jul 2013Drug	CLASS II	Fluphenazine 25 mg/ml Injection recalled by Lowlite Investments	Lowlite Investments	Sterility	Nationwide

Should you stop taking Fluphenazine?

Not on your own. Most recalls affect specific lots from one manufacturer, and stopping a prescription suddenly can be riskier than the defect. Check your lot number and NDC against the recall, then call the pharmacy that dispensed it for a replacement.