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 20 mg per 4 mL because they failed to meet stability specifications — meaning the medication may not remain safe and effective until its printed expiration date. The affected lots were distributed nationwide.
- Check your medication bottle for one of the affected lot numbers (25330415, 25340169, 25380387, 25410936, 25450649, 25471328, 26120385, 26141494, 26170183, or 26220497).
- Contact your pharmacist or healthcare provider if you have one of these lots.
- Do not use the recalled medication without speaking to your healthcare provider first.
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, 20 mg per 4 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-0846-2026More 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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