FDA Drugs recall ·
NAPROXEN ORAL SUSPENSION, USP, 125 mg/5mL, Rx only… recall
- Recall number
- D-0523-2026
- Date
- (initiated April 20, 2026)
- Company / brand
- Acella Pharmaceuticals, LLC
1880 Mcfarland Pkwy Ste 110, Alpharetta, GA, United States - Category
- Drugs › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 6,336 bottles
- Hazard tags
- Microbial contamination
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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
Why was it recalled?
Chemical contamination; presence of lead and lithium above specification
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot: 23F02, Expires: 05/2026; 25A37, Expires: 01/2028.
Distribution
Nationwide
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (drugs), recall D-0523-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.