FDAFDA · Food and drugs·Recall number D-0523-2026
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
Published May 13, 2026 · Recall initiated: April 20, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Chemical contamination; presence of lead and lithium above specification
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- NAPROXEN
- Manufacturer
- Acella Pharmaceuticals, LLC
- Distributor
- Nationwide
- UPC
- 0342192619166
- Lot
- Lot: 23F02, Expires: 05/2026; 25A37, Expires: 01/2028.
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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