Acella Pharmaceuticals, Llc: Naproxen Oral Suspension, Usp, 125 Mg/5ml
Naproxen Oral Suspension Recall Summary Acella Pharmaceuticals is recalling Naproxen Oral Suspension 125 mg/5mL (a pain and fever reducer) distributed nationwide because the product contains elevated levels of lead and lithium that exceed acceptable limits. The recall affects 16-ounce bottles distributed across all 50 states and Washington, D.C.
- Recalling firm
- 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
- Category
- drug recall
- Country
- United States
- Agency
- U.S. Food and Drug Administration
- Recall date
- 2026-04-20
- Status
- Ongoing
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- Nationwide
Official recall notice from U.S. Food and Drug Administration
Recall details on Nibble Recalls: https://trynibble.app/recalls/8d652e26-11e3-46a9-b391-74c00070c25a