Official recall notice

FDA DrugClass IINotable

FDA Recall: Fluphenazine HCl Elixir, USP, 5 mg per 1 mL, Delivers: 10 mL, Oral Elixir, PAI, Alcohol 14% by volum

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 #:25330169; Exp :08/25/2026 Lot #:25340107; Exp :09/04/2026 Lot #:25370044; Exp :09/30/2026 Lot #:25391430; Exp :10/30/2026 Lot #:25411035; Exp :11/13/2026 Lot #:25461036; Exp :12/12/2026 Lot #:25450206; Exp :12/12/2026 Lot #:25521269; Exp :02/03/2027 Lot #:26030426; Exp :02/09/2027 Lot #:26071765; Exp :03/11/2027 Lot #:26111371; Exp :03/24/2027 Lot #:26121435; Exp :03/31/2027 Lot #:26141209; Exp :04/07/2027 Lot #:26151211; Exp :04/13/2027 Lot #:26170561; Exp :04/23/2027 Lot #:26171144; Exp :04/24/2027 Lot #:26191168; Exp :05/08/2027 Lot #:26210307; Exp :05/21/2027 Lot #:26231182; Exp :06/04/2027 Lot #:26241285; Exp :06/15/2027

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