FDAClass II · Drug · Recalled May 13, 2026

NAPROXEN ORAL SUSPENSION recall — Acella Pharmaceuticals, LLC

Hazard: Chemical contamination; presence of lead and lithium above specification

Class II: may cause temporary or medically reversible health consequences.

View the official FDA enforcement record (openFDA) ↗

Official recall ID: D-0523-2026
Brand: Acella Pharmaceuticals
Classification: Class II
Units affected: 6,336 bottles
Recall status: Ongoing
Initiated: Voluntary: Firm initiated

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

Affected products

NAPROXEN ORAL SUSPENSION

Companies & origin

Recalling firm location: Alpharetta, GA, United States
Firm address: 1880 Mcfarland Pkwy Ste 110, 30005-1795

Identifying details (verbatim from the notice)

Product codes / lots: Lot: 23F02, Expires: 05/2026; 25A37, Expires: 01/2028.
Distribution: Nationwide
Firm notified the public via: Letter
FDA event ID: 98781
Recall initiated: April 20, 2026
FDA classified: May 6, 2026
FDA report date: May 13, 2026

Source: U.S. Food & Drug Administration. This page mirrors the official public-domain record verbatim; the linked government source is authoritative. Source last checked July 24, 2026 at 12:00 AM UTC.

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