FDA recall D-0844-2026

Product

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

Reason for recall

Failed Stability Specifications

Distribution

Nationwide in the USA.

Key facts

Status

Ongoing

Initiation date

2026-08-13

Report date

2026-09-23

Voluntary/Mandated

Voluntary: Firm initiated

Location

Woburn, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0844-2026