Rising Pharma recalls Duloxetine DR Capsules 60mg (NDC 57237-019-30, 57237-019-90, 57237-019-99) due to presence of N-nitroso-duloxetine impurity above safety limits. Consumers should check product details and contact Rising Pharma for guidance.
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit
Rising Pharma is recalling Duloxetine DR Capsules 60mg in various pack sizes due to a chemical impurity that could pose health risks. This recall is important because the impurity levels exceed safety thresholds, potentially leading to adverse health effects.
The recall is due to the presence of N-nitroso-duloxetine impurity in the medication, which exceeds 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 Duloxetine DR Capsules 60mg in the specified pack sizes from Rising Pharmaceuticals or distributors are affected. Those taking the medication for depression or other conditions are at risk if they use the recalled products.
Check for the product names and NDC codes: 57237-019-30 (30-count), 57237-019-90 (90-count), and 57237-019-99 (1000-count). The recall includes specific batch numbers and expiration dates listed in the product details.
Identify the NDC code and batch numbers on the product label to determine if it is part of the recall.
The recall is due to the presence of N-nitroso-duloxetine impurity above the recommended safety limits, which could pose health risks.
The recall notice does not specify a remedy, so contact Rising Pharma directly for guidance on next steps.
Check the NDC code on the product label; the recalled products have specific NDC numbers (57237-019-30, 57237-019-90, 57237-019-99) and associated batch numbers and expiration dates.
We’ve drafted a message you can send Rising Pharma to request your refund or repair — edit it as you like.
Subject: Recall D-0107-2025 — Rising Pharma Rising Pharma Hello, I own a Rising Pharma that is covered by recall D-0107-2025 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.
