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FDARecalled May 13, 2026 · #D-0523-2026

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

Hazard

Class II — temporary health risk

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Description

Chemical contamination; presence of lead and lithium above specification Classification: Class II Distribution: Nationwide

Product details

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
Type
Drugs
Manufacturer
Acella Pharmaceuticals, LLC
Model numbers
23F02
UPCs