FDA-Drug2026-09-23Class IICHEMICAL
Safecor Health Fluphenazine HCl Elixir recalled for failed stability specifications
What this means
Safecor Health is recalling multiple lots of Fluphenazine HCl Elixir (5 mg per 1 mL) because the medication failed to meet stability specifications. This means the drug's strength, purity, or safety characteristics may not be reliable. The recall affects 19 lots distributed nationwide.
- Check if you have this medication by looking at the lot number and expiration date on the bottle label.
- Contact your pharmacist or prescriber if you have one of the affected lots.
- Do not use the medication without speaking to your pharmacist or doctor first.
- Return the medication to your pharmacy for proper disposal.
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 1 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-0842-2026More 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
Want us to check the next one for you?
We read every CPSC, FDA, USDA, and NHTSA notice and email you a plain-English Sunday brief covering your household — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.