Acella Pharmaceuticals, LLC recalls NAPROXEN ORAL SUSPENSION
- Recalling company
- Acella Pharmaceuticals, LLC
- Product
- 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
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Apr 20, 2026
- Reported
- May 13, 2026
- Distribution
- Nationwide
- Status
- Ongoing
- Quantity
- 6,336 bottles
- Lot / codes
- Lot: 23F02, Expires: 05/2026; 25A37, Expires: 01/2028.
- Company location
- Alpharetta, GA
- Recall type
- Voluntary: Firm initiated
- Recall number
- D-0523-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number D-0523-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.