Recall: D-0841-2026

Class II - Potentially Harmful

Class IIClassification

2026-08-13Initiated

OngoingStatus

Safecor Health, LLCFirm

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

Reason

Failed Stability Specifications

Distribution

Nationwide in the USA.

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.