FDAHealthApril 20, 2026
Acella Pharmaceuticals, LLC — 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
⚠️ Chemical contamination; presence of lead and lithium above specification
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- April 20, 2026
Nationwide
What's affected?
- 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
- Brand
- NAPROXEN
- UPC
- 0342192619166
- Lot code
- 23F02
Additional details
Lot: 23F02, Expires: 05/2026; 25A37, Expires: 01/2028.
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 6,336 bottles.
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