Naproxen Oral Suspension USP 125 mg/5mL
Acella Pharmaceuticals is recalling Naproxen Oral Suspension 125 mg/5mL (NDC 42192-619-16) due to lead and lithium contamination above specification.
Stop using this medication immediately. Contact your pharmacy or healthcare provider for a replacement or alternative medication. Do not flush or throw away the medication; return it to your pharmacy for proper disposal.
Why it was recalled
Chemical contamination; presence of lead and lithium above specification
How to identify it
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
Where it was sold
Distributed in US.
Official source
Editorial summary by Recall Canary · last updated 2026-05-07 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification