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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

Chemical contamination; presence of lead and lithium above specification

Class II Medicine & devices FDA May 13, 2026 Reached Texas
Read the official FDA notice →

What to do

Stop using the product and check it against the description above. Follow the remedy on the official notice; most recalls are refunded or replaced without a receipt. If you or a family member has already been affected, keep the packaging and the lot code — they're what a claim rests on later.

Details

Recalling company
Acella Pharmaceuticals, LLC — Alpharetta, GA
Severity
Class II — moderate
Reported
May 13, 2026
Quantity
6,336 bottles
Recall number
D-0523-2026
Status
Ongoing
Source
FDA

Where it went

Nationwide

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