Recall: D-0523-2026

Class II - Potentially Harmful

Class IIClassification

2026-04-20Initiated

OngoingStatus

Acella Pharmaceuticals, LLCFirm

Product

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

Reason

Chemical contamination; presence of lead and lithium above specification

Distribution

Nationwide

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