Official recall notice

FDA DrugClass IINotable

FDA Recall: Fluphenazine HCl Elixir, USP, 10 mg per 2 mL, Delivers: 10 mL, Oral Elixir, PAI, Alcohol 14% by volu

Recall date
2026-09-23
Category
Drug
FDA class
Class II

Why it was recalled

Hazard

Failed Stability Specifications

Product description

Failed Stability Specifications

Affected products

Lot#:25421159; Exp :10/21/2026 Lot#:25431644; Exp :11/03/2026 Lot#:25471687; Exp :12/02/2026 Lot#:25510930; Exp :01/05/2027 Lot#:26130247; Exp :04/17/2027 Lot#:25450648; Exp :11/30/2026 Lot#:26061716; Exp :02/28/2027 Lot#:26120384; Exp :03/27/2027 Lot#:26141493; Exp :04/07/2027 Lot#:26190055; Exp :05/04/2027 Lot#:26231530; Exp :06/05/2027

Verify with the official notice →
Share:

Related Recalls

2026-09-23 · FDA_DRUG
FDA Recall: Fluphenazine HCl Elixir, USP, 5 mg per 10 mL, Delivers: 10 mL, Oral Elixir, PAI, Alcohol 14% by volu
Safecor Health, LLC
2026-09-23 · FDA_DRUG
FDA Recall: Fluphenazine HCl Elixir, USP, 5 mg per 1 mL, Delivers: 10 mL, Oral Elixir, PAI, Alcohol 14% by volum
Safecor Health, LLC
2026-09-23 · FDA_DRUG
FDA Recall: Fluphenazine HCl Elixir, USP, 2.5 mg per 5 mL, Delivers: 5 mL, Oral Elixir, PAI, Alcohol 14% by volu
Safecor Health, LLC
2026-09-23 · FDA_DRUG
FDA Recall: Fluphenazine HCl Elixir, USP, 15 mg per 3 mL, Delivers: 10 mL, Oral Elixir, PAI, Alcohol 14% by volu
Safecor Health, LLC