Safecor Health Recalls Fluphenazine HCl Elixir Due to Stability Failures
Safecor Health is recalling Fluphenazine HCl Elixir because it failed stability specifications. The product was distributed nationwide in the USA.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 temporary or medically reversible adverse health consequence. The source text does not report specific injuries or illnesses, fitting the Moderate severity criteria for a standard Class II drug recall without reported harm.
Plain-English summary
Safecor Health, LLC is recalling Fluphenazine HCl Elixir, USP, 20 mg per 4 mL, 10 mL oral elixir. The recall was initiated because the product failed stability specifications.
The affected product is packaged by Safecor Health in Woburn, MA, and is distributed nationwide in the USA. Specific lot numbers and expiration dates are listed in the recall details.
Consumers should stop using the recalled product and contact their healthcare provider or pharmacist for guidance on replacement or disposal.
The recalled product
- Product
- Fluphenazine HCl Elixir, USP, 20 mg per 4 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 (11)
- 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
Distribution
Distributed nationwide across the United States.
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