Acella Naproxen Suspension Recall: Lead and Lithium Contamination Risk
Acella Pharmaceuticals recalls 125mg/5mL naproxen suspension bottles due to lead and lithium contamination exceeding safety limits. Consumers should contact the manufacturer for details.
Recall notice
Chemical contamination; presence of lead and lithium above specification
Contact the company
What happened, in plain English
Acella Pharmaceuticals is recalling certain naproxen suspension bottles because they contain unsafe levels of lead and lithium. This could pose health risks if the medication is used as intended. Read more at govinfonow.com/recall/31344-acella-naproxen-suspension-recall-lead-and-lithium-contamination-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/31344-acella-naproxen-suspension-recall-lead-and-lithium-contamination-risk · Updated August 17, 2026 · FDA enforcement record: FDA #D-0523-2026
Cite this page
“Acella Naproxen Suspension Recall: Lead and Lithium Contamination Risk.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/31344-acella-naproxen-suspension-recall-lead-and-lithium-contamination-risk. Based on FDA recall #D-0523-2026 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0523-2026%22&limit=1).
Why it’s dangerous
The medication contains lead and lithium levels above the safety standards set by regulatory agencies. These contaminants could cause health issues if the product is ingested, especially in long-term use.
Who’s affected
People who have the specific 125mg/5mL naproxen suspension bottles with NDC 42192-619-16 or 25A37 labels are affected. Those using prescription pain relief medications are most at risk.
How to tell if you have this one
Check for bottles labeled 'NAPROXEN ORAL SUSPENSION, USP, 125 mg/5mL, Rx only' with NDC 42192-619-16 or 25A37. The bottles were made in Canada and distributed by Acella Pharmaceuticals.
- Brand
Acella Pharmaceuticals- Category
Drug
What to do — step by step
Contact Manufacturer
Reach out to Acella Pharmaceuticals for specific instructions on what to do with the recalled product.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 23 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0523-2026 (April 20, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0523-2026 to see it in context.
- Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.