Acella recalls naproxen oral suspension over lead and lithium contamination
The recalled naproxen liquid, a prescription medicine sold in 16 fl oz (473 mL) bottles, contains lead and lithium above the allowed limits, and the notice covers 6,336 bottles sold nationwide.
What to do
The notice does not give instructions. Read the official notice for details.
Note from Recalled Today: Don't stop taking a prescribed medicine before you talk to your pharmacist or doctor.
Recall details
- 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
- Company
- Acella Pharmaceuticals, LLC
- Hazard
- Chemical contamination; presence of lead and lithium above specification
- Units
- 6,336 bottles
- Where sold
- Nationwide
- FDA classification
- Class II · Ongoing
- Classified by FDA
- May 6, 2026
- Recall started
- April 20, 2026
- FDA enforcement report
- May 13, 2026
- Identifiers
- Codes: Lot: 23F02, Expires: 05/2026; 25A37, Expires: 01/2028.
- FDA recall number: D-0523-2026
The headline, summary and steps above are written in plain English from the official notice below. Identifiers are copied exactly as the agency published them. Always check the official notice before you act.
Official notice
The notice's own wording from FDA.
- 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 for recall
- Chemical contamination; presence of lead and lithium above specification
- Classification
- Class II (Ongoing)
- Distribution
- Nationwide
- Quantity
- 6,336 bottles
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