Acella Pharmaceuticals, LLC recalls NAPROXEN ORAL SUSPENSION, USP, 125 mg/5mL, Rx only, 16fl oz (473 mL) bottles, Distributed by: Acella Pharmaceuticals, L…

Recall date

April 20, 2026

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0523-2026

FDA classification

Class II

Brand / firm

Acella Pharmaceuticals, LLC

Sold / distributed

Nationwide

Why it was recalled

Chemical contamination; presence of lead and lithium above specification

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

NAPROXEN ORAL SUSPENSION, USP, 125 mg/5mL, Rx only, 16fl oz (473 mL) bottles, Distributed by: Acella Pharmaceuticals, LLC, Alpharetta, GA 30005, Made in Canada NDC 42192-619-16