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 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 situation where use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences. The source text indicates a failure of stability specifications without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Safecor Health, LLC is recalling specific lots of Fluphenazine HCl Elixir, USP, 5 mg per 10 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 only.
The recall covers seven specific lots with expiration dates ranging from 01/18/2026 to 06/18/2027. The affected lots are: 26220866, 25321477, 25471651, 25500133, 26161398, 26170946, and 26240033. The product was distributed nationwide in the USA.
Consumers and healthcare providers should check their inventory for the specific lot numbers and expiration dates listed above. If the product matches the recalled lots, it should be discontinued and returned to the supplier or destroyed according to local regulations. Patients should consult their healthcare provider for alternative treatment options if necessary.
The recalled product
- Product
- Fluphenazine HCl Elixir, USP, 5 mg per 10 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: 00121-0654-16
- 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#:26220866
- Exp :06/18/2027 Lot#:25321477
- Exp :0/18/2026 Lot#:25471651
- Exp :12/01/2026 Lot#:25500133
- Exp :12/19/2026 Lot#:26161398
- Exp :12/31/2026 Lot#:26170946
- Exp :05/15/2027 Lot#:26240033
- Exp :05/31/2027
Distribution
Distributed nationwide across the United States.
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