Official recall notice

FDA DrugClass IINotable

FDA Recall: NAPROXEN ORAL SUSPENSION, USP, 125 mg/5mL, Rx only, 16fl oz (473 mL) bottles, Distributed by: Acella

Recall date
2026-05-13
Category
Drug
FDA class
Class II

Why it was recalled

Hazard

Chemical contamination; presence of lead and lithium above specification

Recommended action

What to do

6,336 bottles

Product description

Chemical contamination; presence of lead and lithium above specification

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