Acella Pharmaceuticals, LLC recalls NAPROXEN ORAL SUSPENSION, USP, 125 mg/5mL, Rx only, 16fl oz (473 mL) bottles, Distributed by: Acella Pharmaceuticals, LL
Recalled May 13, 2026 · FDA recall D-0523-2026 · Acella Pharmaceuticals
Hazard
Chemical contamination; presence of lead and lithium above specification · FDA Class II
Units
6,336 bottles
Sold at
Nationwide
Description
Chemical contamination; presence of lead and lithium above specification
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
Manufacturer(s)
Acella Pharmaceuticals, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →