Class II

Drug Recall: 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

Acella Pharmaceuticals, LLC · April 20, 2026

Reason for Recall

Chemical contamination; presence of lead and lithium above specification

Distribution

Nationwide

States Affected

NATIONWIDE

Quantity Affected

6,336 bottles

Source: FDA (openFDA Drug Enforcement)

Recall number: D-0523-2026

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.