Acella Pharmaceuticals, Llc: Naproxen Oral Suspension, Usp, 125 Mg/5ml

Recalling firm
Acella Pharmaceuticals, LLC
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
Reason
Chemical contamination; presence of lead and lithium above specification
Classification
Class II
Category
drug recall
Country
United States
Agency
U.S. Food and Drug Administration
Recall date
2026-04-20
Status
Ongoing
Areas affected
AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
Distribution
Nationwide

Official recall notice from U.S. Food and Drug Administration

Recall details on Nibble Recalls: https://trynibble.app/recalls/5e6ef809-bc1f-431d-9bda-771fad72f3d5