Notice names this product. Acella Pharmaceuticals’s NAPROXEN ORAL SUSPENSION is named in FDA Class II recall D-0523-2026. Your particular item is not yet verified. Compare the identifiers and exclusions in the notice before deciding whether it applies. Agency-reported hazard: Chemical contamination; presence of lead and lithium above specification Identifying details: Lot: 23F02, Expires: 05/2026; 25A37, Expires: 01/2028.. Units affected: 6,336 bottles. Status: Ongoing.
This notice names a product; your particular item is not yet verified. Compare every applicable model, serial, lot, production-date or model-year boundary below.
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
Still to verify: match the label on your item with the full official notice, including any exclusions, tables and photos. Some identifiers appear only on the agency website and are absent from this data feed. A missing field does not mean all versions are affected.
If your lot or date falls outside a stated range, this notice has not established that your item is affected. This is not a finding about other recalls or product safety.
Chemical contamination; presence of lead and lithium above specification
Company / brand: Acella Pharmaceuticals recalls
Affected product: NAPROXEN ORAL SUSPENSION recall status
Official ID D-0523-2026 · Official record ↗
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Compiled from connected official public-domain government data. Sources last checked October 22, 2026 at 6:00 PM UTC.