Class IIDrug
Fluphenazine HCl Elixir recall
Summary
Safecor Health, LLC is recalling Fluphenazine HCl Elixir (drug). According to the FDA report, the reason is: Failed Stability Specifications. The FDA rated this a Class II: the product may cause temporary or medically reversible health problems; serious harm is unlikely. Recall status: Ongoing.
Details from the FDA report
- 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
- Reason
- Failed Stability Specifications
- Lot / code info
- 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
- Quantity
- N/A
- Distribution
- Nationwide in the USA.
- Recalling company
- Safecor Health, LLC, Woburn, MA United States
- Recall started
- August 13, 2026
- FDA report date
- September 23, 2026
- Classification
- Class II: The product may cause temporary or medically reversible health problems; serious harm is unlikely.
- Voluntary / mandated
- Voluntary: Firm initiated
- Status
- Ongoing
- Recall number
- D-0843-2026
What to do
- Check whether you have this product, and compare the lot numbers, codes, or dates on your package with the codes listed above.
- If it matches, stop using it and keep it away from children and pets.
- Contact the recalling company (Safecor Health, LLC) or the store where you bought it about returns or refunds.
- Do not stop a prescribed medication without first talking to your pharmacist or doctor; they can help find a safe replacement.
- If you think the product made you or someone else sick, contact a doctor or pharmacist. In an emergency call 911.
- You can report problems to the FDA via MedWatch.