FDA · Drugs · Wednesday, May 13

NAPROXEN ORAL SUSPENSION, USP, 125 mg/5mL, Rx only recall

Acella Pharmaceuticals, LLC recalled NAPROXEN ORAL SUSPENSION, USP, 125 mg/5mL, Rx only on May 13, 2026 because of chemical contamination; presence of lead and lithium above specification. It was sold nationwide.

Why it was recalled

Chemical contamination; presence of lead and lithium above specification

What's recalled

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

Quantity: 6,336 bottles

What to do

Check whether you have the product (match the lot numbers, dates or codes in the official notice). Stop using it, and return it or throw it away as the notice says.

Read the official FDA notice

Details

Company: Acella Pharmaceuticals, LLC, Alpharetta, GA
Date: Wednesday, May 13
Severity: Class II
the product could cause temporary or reversible health problems.
Where sold: Nationwide
Status: Ongoing
Recall number: D-0523-2026
Source: U.S. Food and Drug Administration

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