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 was distributed nationwide.
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 FDA classified this as a Class II recall. The source text does not report any illnesses, injuries, or deaths, and the hazard is related to stability specifications rather than a high-risk pathogen or structural defect, fitting the Moderate criteria for low-risk contamination or voluntary precautionary recalls.
Plain-English summary
Safecor Health, LLC is recalling specific lots of Fluphenazine HCl Elixir, USP, 2.5 mg per 5 mL. The recall was initiated because the product failed stability specifications. The affected product is an oral elixir containing 14% alcohol by volume and is labeled for oral use only.
The recall covers seven specific lots with expiration dates ranging from November 2026 to May 2027. The affected lots were distributed nationwide in the United States. The FDA has classified this recall as Class II, which indicates a situation that might cause temporary or medically reversible adverse health consequences.
Consumers and healthcare providers should check their inventory for the specific lot numbers listed in the recall notice. If the product is found, it should be discontinued and returned to the distributor or manufacturer. Patients should consult their healthcare provider for alternative treatment options if they are currently using this medication.
The recalled product
- Product
- Fluphenazine HCl Elixir, USP, 2.5 mg per 5 mL, Delivers: 5 mL, Oral Elixir, PAI, Alcohol 14% by volume, For Oral Use Only, Rx Only, Pkg by: Safecor Health, Woburn, MA 01801. NDC: 00121-0654-16
- 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 (8)
- Lot#26160463
- Exp :04/20/2027 Lot#25430188
- Exp :11/26/2026 Lot#25440715
- Exp :12/9/2026 Lot#25501160
- Exp :01/21/2027 Lot#26021054
- Exp :02/5/2027 Lot#26130635
- Exp :04/3/2027 Lot#26200964
- Exp :05/13/2027
Distribution
Distributed nationwide across the United States.
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