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 2.5 mg per 5 mL because they failed stability testing, meaning the medication may not maintain its strength or safety over time. The affected lots were distributed nationwide.
- Check if you have one of the affected lots (see lot numbers and expiration dates on the FDA notice).
- Contact your pharmacy or healthcare provider if you have this medication.
- Do not use affected lots without speaking to your pharmacist or doctor 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, 2.5 mg per 5 mL, Delivers: 5 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-0841-2026More 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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