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Medium risk Drugs & MedicationsClass II

Safecor Health, LLC Recall

Fluphenazine HCl Elixir, USP, 15 mg per 3 mL, Delivers: 10 mL, Oral Elixir, PAI, Alcohol 14% by volume, For Oral Use Only, Rx Only, Pkg by:

Updated August 13, 2026

Safecor Health, LLC is recalling Fluphenazine HCl Elixir, USP, 15 mg per 3 mL, Delivers: 10 mL, Oral Elixir, PAI, Alcohol 14% by volume, For Oral Use Only, Rx Only, Pkg by:. Hazard: Failed Stability Specifications

Is the Safecor Health, LLC recalled? Yes. This product was recalled by FDA on August 13, 2026. Details below.

What is recalled

Fluphenazine HCl Elixir, USP, 15 mg per 3 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

Am I affected

You may be affected if you own this product. Check the brand, model, and lot/date codes listed in the recall against your item.

What to do right now

Voluntary: Firm initiated

The hazard

Failed Stability Specifications

Brands affected

Safecor Health, LLC
Source
FDA
Category
Drugs & Medications
Recall ID
fda-D-0845-2026
Classification
Class II
Recalled
August 13, 2026
Read the official notice

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