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Naproxen Oral Suspension
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DRUG RECALLMODERATE

Naproxen Oral Suspension

Acella Pharmaceuticals is recalling Naproxen Oral Suspension, 125 mg/5mL, distributed nationwide due to lead and lithium contamination.

What to do

Stop using this product immediately and contact your healthcare provider or pharmacist for further guidance.

Recalled
Listed
Updated
Recall No.
D-0523-2026
Agency
FDA
Firm
Acella Pharmaceuticals, LLC
Recall ID
98781
Status
ONGOING

Recall at a glance

Quantity recalled
6,336 bottles

Why it was recalled

Acella Pharmaceuticals is recalling Naproxen Oral Suspension, USP, 125 mg/5mL, distributed nationwide due to chemical contamination, specifically levels of lead and lithium that exceed safety specifications.

Is mine affected?

Check the NDC or UPC and strength printed on the package. Yours is affected if it matches one below.

NAPROXEN ORAL SUSPENSION, USP

Lot code
23F02, 2026
Strength
125 mg
NDC / UPC
NDC 42192-619-16

Where it was sold

Distributed nationwide.

Timeline

  1. Firm initiated recall
  2. Publicly announced
  3. Listed on Recall Canary
  4. Summary updated

Official source

View on U.S. Food and Drug Administration →

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Editorial summary by Recall Canary · summary updated 2026-06-11 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification