Reported May 13, 2026 · Ongoing
NAPROXEN ORAL SUSPENSION, USP, 125 mg/5mL, Rx only, 16fl oz (473 mL) bottles, Distributed by: Acella Pharmaceuticals,…
Acella Pharmaceuticals, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Acella Pharmaceuticals, LLC · 1880 Mcfarland Pkwy Ste 110 · Alpharetta, GA · 30005-1795
Is this the product you have?
- NAPROXEN ORAL SUSPENSION, USP, 125 mg/5mL, Rx only, 16fl oz (473 mL) bottles
- Distributed byAcella Pharmaceuticals, LLC, Alpharetta, GA 30005, Made in Canada NDC 42192-619-16
- Lot codes and dates
- Lot23F02
- Expires
05/202625A37
- Expires01/2028
- Amount recalled
- 6,336 bottles
Where it was sold
- Nationwide
Why it was recalled
Chemical contamination; presence of lead and lithium above specification
This product could cause temporary or reversible health problems — stop using it.
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