Rising Pharma recalls Duloxetine Delayed-Release Capsules 30mg (NDC 57237-018-30) and 90mg (NDC 57237-018-90) due to presence of N-nitroso-duloxetine impurity above safety limits. This may pose health risks.
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit
Rising Pharma is recalling Duloxetine Delayed-Release Capsules 30mg and 90mg products because they contain a harmful impurity that could pose health risks. This recall affects people who have taken these specific capsules and may need to stop using them.
The capsules contain N-nitroso-duloxetine impurity levels above the recommended safety limits. This impurity could potentially cause health issues, though the exact risk level is not clearly specified in the recall notice.
People who have purchased or received the recalled Duloxetine capsules from Rising Pharma. Those with specific medical conditions or taking other medications may be at higher risk.
Check for the product name 'Duloxetine Delayed-Release Capsules USP, 30 mg' with NDC 57237-018-30 or 'Duloxetine Delayed-Release Capsules USP, 90 mg' with NDC 57237-018-90. These are prescription-only products distributed by Rising Pharma Holdings, Inc.
Look for the NDC codes 57237-018-30 or 57237-018-90 on the packaging to confirm if your capsules are recalled.
The recall states that the product contains a harmful impurity above safety limits, but the exact health risk is not clearly described. It is recommended to check if your product is recalled before using.
Check for the NDC codes 57237-018-30 or 57237-018-90 on the packaging. These are the specific recalled products.
The recall does not specify a remedy, so you should contact Rising Pharma directly for guidance on next steps.
We’ve drafted a message you can send Rising Pharma to request your refund or repair — edit it as you like.
Subject: Recall D-0106-2025 — Rising Pharma Rising Pharma Hello, I own a Rising Pharma that is covered by recall D-0106-2025 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.
