Limited official informationFDA Drug Enforcement ReportsRecall date: May 13, 2026

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

Full official product 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

1Is my item affected?

Compare the complete identifiers. Name similarity alone is not a confirmed match.

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

Identifiers to compare

NDC 42192-619-16
Lot 23F02

Affected variants from the official event record
Product or model	Codes and lots	Quantity	Recall number
NAPROXEN ORAL SUSPENSION, USP, 125 mg/5mL, Rx only, 16fl oz (473 mL) bottles, Distributed by: Acella Pharmaceuticals, LLC, Alpharetta, GA 30005, Made in Cana...	Lot: 23F02, Expires: 05/2026; 25A37, Expires: 01/2028.	6,336 bottles	D-0523-2026

2What is the risk?

The agency's statement is shown without a site-authored severity score.

Chemical contamination; presence of lead and lithium above specification

Agency classification: Class II

3What should I do?

Only instructions associated with this recall event qualify as an action.

Consumer action is not available in the associated official record. The site does not infer or generate a replacement.

Verify on the official source

The linked agency record controls if any information differs.

Official evidence

U.S. Food and Drug Administration authoritative
openFDA Drug authoritative

Official scope

Distribution reported by the agency

Nationwide

Distribution is context, not a confirmed item match. Compare the model, lot, UPC, NDC, or serial number above.

Material change history

No material affected-item, risk, action, or status change has been recorded since this page entered the tracker.