FDAFDA · Food and drugs·Recall number D-0845-2026
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
Published September 23, 2026 · Recall initiated: August 13, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Stability Specifications
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Safecor Health, LLC
- Distributor
- Nationwide in the USA.
- Lot
- Lot#:26080483; Exp :03/13/2027 Lot#:25310327; Exp :08/12/2026 Lot#:25330414; Exp :08/26/2026 Lot#:25430340; Exp :11/22/2026
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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