Drug FDA Class II Ongoing cGMP deviation

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

Acella Pharmaceuticals, LLC Published May 13, 2026

Risk level

Class II

May cause a temporary or reversible health problem; slight chance of serious harm.

Severity score 68/100

What should you do?

Check whether you have this product, using the lot codes, UPCs, and dates listed below.
Do not eat, serve, or sell the affected product.
Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
Contact Acella Pharmaceuticals, LLC or your place of purchase with questions, and see the source record below for full details.

Reason for recall

Chemical contamination; presence of lead and lithium above specification

Hazards

Lead · primaryLithium

Affected products (1)

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

NAPROXEN · 6,336 bottles

NDC: 42192-619, 42192-619-16

Lot codes: 23F02

Code info: Lot: 23F02, Expires: 05/2026; 25A37, Expires: 01/2028.

Affected areas

Nationwide

Timeline

Initiated

Apr 20, 2026
Published

May 13, 2026

Recall number: D-0523-2026
Agency: U.S. Food and Drug Administration
Country: US

Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.