⚠ RecallRadar📷 ScanGuidesOfficial U.S. recall notices, restated plainly

Acella Pharmaceuticals, LLC: NAPROXEN ORAL SUSPENSION, USP, 125 mg/5mL, Rx only, 16fl oz (473 mL) bottles, Distributed by: Acella Pharmaceuticals, LLC, Alpharetta, GA 30

DrugsSource: FDA (drug) · Date: 2026-05-13

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The text below is copied from the official FDA (drug) record. If anything differs, the official notice is correct.

Company / brand
Acella Pharmaceuticals, LLC
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
Reason / hazard
Chemical contamination; presence of lead and lithium above specification
Classification
Class II
Status
Ongoing
Distribution / sold at
Nationwide
Recall initiated
2026-04-20
Code info
Lot: 23F02, Expires: 05/2026; 25A37, Expires: 01/2028.
Product quantity
6,336 bottles
Voluntary mandated
Voluntary: Firm initiated
City
Alpharetta
State
GA
Country
United States
Event id
98781
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