FDA recall, , Moderate risk
Acella Naproxen Oral Suspension
Naproxen oral suspension contains lead and lithium above specification.
Summary by Recall Canary from the FDA notice
What happened
Acella Pharmaceuticals, LLC of Alpharetta, Georgia began a recall of Naproxen Oral Suspension, USP, 125 mg/5mL, Rx only, 16fl oz (473 mL) bottles on April 20, 2026, due to chemical contamination from lead and lithium above specification. The product, distributed nationwide and made in Canada, was added to the FDA's Enforcement Report on May 6, 2026.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medicine recalls:
- Check the FDA or company notice for instructions specific to this product.
- Ask your pharmacist or doctor whether your lot is affected and what to do.
Is yours affected?
Match the NDC and lot code listed under your product.
An NDC (National Drug Code) is usually printed on the drug's label.
Naproxen Oral Suspension, USP, 125 mg/5mL
- NDC
- 42192-619-16
- Lot code
- 23F02
- 25A37
Recall details
- Company began the recall
- Sold in
- Nationwide
- Company
- Acella Pharmaceuticals, LLCAlpharetta, Georgia
- Hazard
- Chemical contamination
- Risk
Moderate risk
Taking it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98781
- Recall number
- D-0523-2026
- Quantity recalled
- 6,336 bottles
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
