Naproxen Oral Suspension recall: Contamination
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 Naproxen Oral Suspension recalled?
Chemical contamination; presence of lead and lithium above specification
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot: 23F02, Expires: 05/2026; 25A37, Expires: 01/2028.
- 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
- Recalling firm
- Acella Pharmaceuticals, LLC
- Quantity
- 6,336 bottles
- Distribution
- Nationwide
- Recall date
- May 13, 2026
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (drug)