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Class II · ModerateActive recall

Naproxen

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberLot: 23F02, Expires: 05/2026; 25A37, Expires: 01/2028.
Where it was soldNationwide
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

Chemical contamination; presence of lead and lithium above specification

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byMade in Canada foreign manufacturer
Brand nameNAPROXEN
Generic nameNAPROXEN
Active ingredient(s)NAPROXEN
Distributed by / forAcella Pharmaceuticals, LLC, Alpharetta, GA 30005
NDC42192-619-16
Show the full FDA record
Full product labelNAPROXEN 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 firmAcella Pharmaceuticals, LLC
DistributionNationwide
Quantity6,336 bottles
Recall initiated2026-04-20
Report date2026-05-13
Recall completed—
Recall numberD-0523-2026
ClassificationClass II
FDA statusOngoing
Origin on fileAlpharetta GA United States

Related

Recent drug recallsCheck another medication

Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.