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 recall is classified as FDA Class II, which typically involves a temporary or medically reversible adverse health consequence. The source text cites 'Failed Stability Specifications' without reporting specific injuries or illnesses, aligning with the Moderate severity criteria for low-risk contamination or labeling/stability issues.
Plain-English summary
Safecor Health, LLC is recalling specific lots of Fluphenazine HCl Elixir, USP, 15 mg per 3 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 recalled product is identified by NDC 00121-0653-04. The specific lots affected are 26080483 (expiration 03/13/2027), 25310327 (expiration 08/12/2026), 25330414 (expiration 08/26/2026), and 25430340 (expiration 11/22/2026). The product was distributed nationwide in the United States.
Consumers and healthcare providers should check their inventory for these specific lot numbers and expiration dates. If the product matches the recalled lots, it should be discontinued and returned to the supplier or disposed of according to local regulations. No specific instructions for patient management are provided in the source text.
The recalled product
- Product
- Fluphenazine HCl Elixir, USP, 15 mg per 3 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 (5)
- Lot#:26080483
- Exp :03/13/2027 Lot#:25310327
- Exp :08/12/2026 Lot#:25330414
- Exp :08/26/2026 Lot#:25430340
- Exp :11/22/2026
Distribution
Distributed nationwide across the United States.
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