Acella Pharmaceuticals recalls 125mg/5mL naproxen suspension bottles due to lead and lithium contamination exceeding safety limits. Consumers should contact the manufacturer for details.
Chemical contamination; presence of lead and lithium above specification
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.
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.
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.
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.
Reach out to Acella Pharmaceuticals for specific instructions on what to do with the recalled product.
The recall states that the product contains lead and lithium above safety levels, so it is not safe to use as intended.
Look for bottles labeled 'NAPROXEN ORAL SUSPENSION, USP, 125 mg/5mL, Rx only' with NDC 42192-619-16 or 25A37.
Contact Acella Pharmaceuticals for specific instructions on what to do with the recalled product.
We’ve drafted a message you can send Acella Pharmaceuticals to request your refund or repair — edit it as you like.
Subject: Recall D-0523-2026 — Acella Pharmaceuticals Acella Pharmaceuticals Hello, I own a Acella Pharmaceuticals that is covered by recall D-0523-2026 from Acella Pharmaceuticals. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
