Safecor Health, LLC — 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: 0

Official product recall notices and clearly labeled enforcement reference records.

Reference record — not a live warning · enforcement-reference · official-source

Failed Stability Specifications

Provider: FDA — drug enforcement reference
Source observed: 9/23/2026, 12:00:00 AM UTC
Source updated: 9/23/2026, 12:00:00 AM UTC
Location: Woburn, MA, US
hazard: Failed Stability Specifications
notice: Periodic enforcement reference; not a real-time safety alert or a reliable recall-lifecycle tracker.
product: 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
distribution: Nationwide in the USA.
manufacturer: Safecor Health, LLC
recall number: D-0841-2026
source status: Ongoing
classification: Class II
freshness minutes: 180

Source use policy · openFDA reference data; not a real-time public alert service

Update history (1 recent revisions)