United StatesNAPROXEN ORAL SUSPENSION, USP 125 mg/5 mL, Rx only, 16 fl oz (473 mL) bottles distributed by Acella Pharmaceuticals (NDC 42192-619-16), lots 23F02 (exp 05/2026) and 25A37 (exp 01/2028), made in Canada. Acella is recalling these nationwide because testing found chemical contamination with lead and lithium above specification and the recall is ongoing.
What's being 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
Recalling firm: Acella Pharmaceuticals, LLC, Alpharetta, GA, United States.
How to identify it
Lot: 23F02, Expires: 05/2026; 25A37, Expires: 01/2028.
The hazard
Chemical contamination; presence of lead and lithium above specification
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
Nationwide
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)