NAPROXEN ORAL SUSPENSION recall (Acella Pharmaceuticals, LLC)
DrugClass IIOngoing
Summary: Acella Pharmaceuticals, LLC is recalling 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.
What is being recalled
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
Why
Chemical contamination; presence of lead and lithium above specification
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
Nationwide
How to tell if yours is affected
Lot: 23F02, Expires: 05/2026; 25A37, Expires: 01/2028.
What to do
Check the product name, lot number and expiration date on your package against the codes above. If they match, do not stop taking a prescription medicine without talking to your doctor or pharmacist first; ask them about a replacement. Return or dispose of the product as your pharmacy advises.
Recall facts
| Recall number | D-0523-2026 |
| Category | Drug |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | April 20, 2026 |
| Reported | May 13, 2026 |
| Company | Acella Pharmaceuticals, LLC |
| Company location | Alpharetta, GA, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 6,336 bottles |
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