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 10 mg per 2 mL because they failed stability testing. This means the medication may not maintain its strength or safety over time. The recall affects 11 lots distributed nationwide.
- Check the lot number on your medication bottle against the list of recalled lots.
- Do not use recalled lots; contact your pharmacist or doctor for a replacement or alternative medication.
- If you have questions, contact Safecor Health or your pharmacy.
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, 10 mg per 2 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-0844-2026More 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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