HIGH

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

Chemical contamination; presence of lead and lithium above specification

Quick Facts at a Glance

Recall Date
April 20, 2026
Hazard Level
HIGH
Brands
NAPROXEN, Acella Pharmaceuticals, LLC
Geographic Scope
1 states

Hazard Information

Chemical contamination; presence of lead and lithium above specification

What You Should Do

Consumers and healthcare providers should stop using this product immediately. Contact Acella Pharmaceuticals, LLC or your healthcare provider for guidance. Notification method: Letter

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Full Description

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. Generic: NAPROXEN; Brand: NAPROXEN. Reason: Chemical contamination; presence of lead and lithium above specification. Classification: Class II. Quantity: 6,336 bottles. Distribution: Nationwide

Safety Guide

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Product Classification

Product Details

Model Numbers
Lot: 23F02
Expires: 05/2026
25A37
Expires: 01/2028.
UPC Codes
42192-619
42192-619-16
Affected States
ALL
Report Date
May 13, 2026
Source Agency
FDA - Drug Safety
Recall Status
ACTIVE