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FDA · Drugs ·

Fluphenazine HCl Elixir recall

Safecor Health, LLC recalled Fluphenazine HCl Elixir on September 23, 2026 because of failed stability specifications. It was sold nationwide.

Why it was recalled

Failed Stability Specifications

What's recalled

Fluphenazine HCl Elixir, USP, 20 mg per 4 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

Quantity: N/A

What to do

Check whether you have the product (match the lot numbers, dates or codes in the official notice). Stop using it, and return it or throw it away as the notice says.

Read the official FDA notice

Details

Company
Safecor Health, LLC, Woburn, MA
Date
Severity
Class II
the product could cause temporary or reversible health problems.
Where sold
Nationwide
Nationwide in the USA.
Status
Ongoing
Recall number
D-0846-2026
Source
U.S. Food and Drug Administration

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