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FDAClass II

Fluphenazine HCl Elixir, USP, 5 mg per 1 mL, Delivers: 10 mL, Oral Elixir, PAI, Alcohol 1… Recalled: Failed Stability Specifications

Fluphenazine HCl Elixir, USP, 5 mg per 1 mL, Delivers: 10… was recalled on August 13, 2026 in cooperation with the U.S. Food and Drug Administration because failed Stability Specifications.

Is my unit affected?

Fluphenazine HCl Elixir, USP, 5 mg per 1 mL, Delivers: 10 mL, Oral Elixir, PAI, Alcohol 14% by volume, For Oral Use Only, Rx Only, Pkg by: Safecor Health, Woburn, MA 01801. NDC: 00121-0653-04

Model, lot & date codes to check

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

Units affected: N/A

Where it was sold: Nationwide in the USA.

Compare the codes above against the label on your product — usually on the bottom, the back panel, or the packaging. If your unit isn't listed, it is not part of this recall.

What's the hazard?

Failed Stability Specifications

Class II means the product might cause a temporary or medically reversible health problem; the chance of serious harm is remote.

Your remedy & how to claim it

Stop using the product. Return it to the place of purchase for a refund, or dispose of it. Contact the recalling firm with questions.

Contact: Recalling firm: Safecor Health, LLC

Not sure what you're entitled to? Read our guide: what to do if your product is recalled.

Official recall notice

Always confirm details on the official notice from the U.S. Food and Drug Administration before acting.

View official notice →

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