Naproxen Oral Suspension
Acella Pharmaceuticals is recalling Naproxen Oral Suspension, 125 mg/5mL, distributed nationwide due to lead and lithium contamination.
Stop using this product immediately and contact your healthcare provider or pharmacist for further guidance.
Why it was recalled
Acella Pharmaceuticals is recalling Naproxen Oral Suspension, USP, 125 mg/5mL, distributed nationwide due to chemical contamination, specifically levels of lead and lithium that exceed safety specifications.
Is mine affected?
Check the NDC or UPC and strength printed on the package. Yours is affected if it matches one below.
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
- Recall #
- D-0523-2026
Where it was sold
Distributed nationwide.
Official source
Editorial summary by Recall Canary · last updated 2026-06-11 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification