The Recall Desk
ModerateFDA (Drugs)·D-0844-2026·Announced 2026-09-23

Safecor Health Recalls Fluphenazine HCl Elixir Due to Stability Failures

Safecor Health is recalling specific lots of Fluphenazine HCl Elixir because they failed stability specifications. The product is distributed nationwide.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, which typically involves a reasonable probability of temporary or medically reversible adverse health consequences. The source text does not report any specific illnesses, injuries, or fatalities, and the hazard is a failure of stability specifications rather than a direct acute hazard like contamination or mislabeling of a critical allergen.

Plain-English summary

Safecor Health, LLC is recalling specific lots of Fluphenazine HCl Elixir, USP, 10 mg per 2 mL. The recall was initiated because the product failed stability specifications. The affected product is an oral elixir containing 14% alcohol by volume, intended for oral use only, and is available by prescription.

The recall covers eleven specific lots of the medication, with expiration dates ranging from October 2026 to June 2027. The product was distributed nationwide in the United States.

Consumers and healthcare providers should stop using the affected lots and contact their pharmacist or healthcare provider for guidance on replacement or disposal. The recall is limited to the specific lot numbers listed in the official recall notice.

The recalled product

Product
Fluphenazine HCl Elixir, USP, 10 mg per 2 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
Manufacturer
Safecor Health, LLC
Category
Drug — Antipsychotic
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (12)

  • 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

Distribution

Distributed nationwide across the United States.

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