FDA-Drug2026-09-23Class IICHEMICAL
Safecor Health Fluphenazine HCl Elixir recalled for failed stability specifications
What this means
Safecor Health is recalling specific lots of Fluphenazine HCl Elixir 5 mg per 10 mL because they failed stability testing requirements. The affected lots may not maintain their expected strength and safety over their labeled shelf life. This medication is used to treat certain psychiatric conditions.
- Check if you have one of the affected lot numbers: 26220866, 25321477, 25471651, 25500133, 26161398, 26170946, or 26240033.
- Contact your pharmacy or prescriber if you have this medication.
- Do not use the recalled lots without consulting your pharmacist or doctor.
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, 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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0843-2026More 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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