Rising Pharma recalls 1,000-count Duloxetine 30mg capsules (NDC 57237-018-99) due to potential N-nitroso-duloxetine impurity above safety limits. Rx only product distributed by Rising Health, LLC.
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit.
Rising Pharma is recalling 1,000-count Duloxetine 30mg capsules (NDC 57237-018-99) because they contain an impurity that may exceed safety limits. This could pose a risk to people taking the medication as prescribed.
The capsules contain N-nitroso-duloxetine impurities above the recommended safety limit. This impurity could potentially cause harm if taken in the amounts prescribed, though the risk is considered low based on the recall.
People with a prescription for Duloxetine 30mg capsules who received this specific batch (NDC 57237-018-99) from Rising Health, LLC. Those taking the medication for depression or nerve pain are most at risk.
Check for the 1,000-count bottle labeled 'Duloxetine Delayed-Release Capsules, USP, 30 mg' with NDC 57237-018-99. The product was distributed by Rising Health, LLC in Saddle Brook, NJ.
Verify if your bottle has the NDC number 57237-018-99 and was distributed by Rising Health, LLC.
The recall states the product contains an impurity above safety limits, but the risk is considered low. Consult your doctor if you have concerns.
The recall record does not specify a replacement process or remedy.
The recall record does not specify a remedy, so contact Rising Pharma Holding, Inc. directly for guidance.
We’ve drafted a message you can send Rising Pharma to request your refund or repair — edit it as you like.
Subject: Recall D-0277-2025 — Rising Pharma Rising Pharma Hello, I own a Rising Pharma that is covered by recall D-0277-2025 from Rising Pharma. 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.
