Quick Facts at a Glance
- Recall Date
- April 20, 2026
- Hazard Level
- HIGH
- Brands
- NAPROXEN, Acella Pharmaceuticals, LLC
- Geographic Scope
- 1 states
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Drug Safety; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- NAPROXEN, Acella Pharmaceuticals, LLC
- Model numbers
- Lot: 23F02, Expires: 05/2026, 25A37, Expires: 01/2028.
- UPC codes
- 42192-619, 42192-619-16
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
April 20, 2026
Reported by FDA DRUG
May 13, 2026
RecallRadar source check
May 20, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Chemical contamination; presence of lead and lithium above specification
What You Should Do
Consumers and healthcare providers should stop using this product immediately. Contact Acella Pharmaceuticals, LLC or your healthcare provider for guidance. Notification method: Letter
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Full Description
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. Generic: NAPROXEN; Brand: NAPROXEN. Reason: Chemical contamination; presence of lead and lithium above specification. Classification: Class II. Quantity: 6,336 bottles. Distribution: Nationwide
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Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
Read: How to Get Refunds and ReplacementsWant to Know First?
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