FDA recall D-0523-2026

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 for recall

Chemical contamination; presence of lead and lithium above specification

Distribution

Nationwide

Key facts

Status

Ongoing

Initiation date

2026-04-20

Report date

2026-05-13

Voluntary/Mandated

Voluntary: Firm initiated

Location

Alpharetta, GA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0523-2026