Yes — there is an active recall. 10 ongoing FDA recalls mention Fluphenazine (14 total). Check the affected lots below.
Most common reason: Stability / shelf life (6 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Fluphenazine. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Failed impurities/degradation specifications: (OOS) for Organic Impurities by HPLC (Impurity-A) during testing at the 18 months long term stability. Result: 1.1 percent. Spec: 1.0 percent.
Failed Stability Specifications
Failed Stability Specifications
Failed Stability Specifications
Failed Stability Specifications
Failed Stability Specifications
Failed Stability Specifications
CGMP Deviations
CGMP Deviations
Discoloration; Hazy solution found in one vial instead of a clear solution.
Subpotent Drug
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
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