Official recall notice

FDA DrugClass IINotable

FDA Recall: Fluphenazine HCl Elixir, USP, 20 mg per 4 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#:25330415; Exp :08/26/2026 Lot#:25340169; Exp :09/05/2026 Lot#:25380387; Exp :10/17/2026 Lot#:25410936; Exp :11/13/2026 Lot#:25450649; Exp :11/30/2026 Lot#:25471328; Exp :01/05/2027 Lot#:26120385; Exp :03/27/2027 Lot#:26141494; Exp :04/07/2027 Lot#:26170183; Exp :04/21/2027 Lot#:26220497; Exp :05/28/2027

Related Recalls

Fluphenazine HCl Elixir Recall (Sep 2026) – Safecor Health | WatchRecall