FDA-Drug2026-09-23Class IICHEMICAL
Safecor Health Fluphenazine HCl Elixir recalled for failed stability specifications
What this means
Safecor Health is recalling Fluphenazine HCl Elixir (15 mg per 3 mL) in four specific lots because the medication failed to meet stability test requirements. This means the drug may not remain safe and effective through its expiration date. The affected lots were distributed nationwide.
- Check your medication bottle for the lot number and expiration date listed below.
- If you have one of the affected lots, contact your pharmacist or prescriber before stopping the medication.
- Affected lots: #26080483 (Exp 03/13/2027), #25310327 (Exp 08/12/2026), #25330414 (Exp 08/26/2026), #25430340 (Exp 11/22/2026).
The agency's original wording
Hazard
Failed Stability Specifications
Intended for
Adults
Illnesses reported
None reported
Sold states
Nationwide in the USA.
Affected count
N/A
Manufactured in
317 New Boston St, N/A, Woburn, MA, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0845-2026More Safecor Health recalls
- FDA-Drug2026-09-23Safecor Health Fluphenazine HCl Elixir recalled for failed stability specifications
- FDA-Drug2026-09-23Safecor Health Fluphenazine HCl Elixir recalled for failed stability specifications
- FDA-Drug2026-09-23Safecor Health Fluphenazine HCl Elixir recalled for failed stability specifications
- FDA-Drug2026-09-23Safecor Health Fluphenazine HCl Elixir recalled for failed stability specifications
- FDA-Drug2026-09-23Safecor Health Fluphenazine HCl Elixir recalled for failed stability specifications
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