Rising Pharma recalls 20mg Duloxetine Delayed-Release Capsules (NDC 57237-017-60) with specific lot numbers due to presence of N-nitroso-duloxetine impurity above safety limits. Consumers should check their bottles for listed lot numbers and contact the company for guidance.
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit
Rising Pharma is recalling 20mg Duloxetine Delayed-Release Capsules bottles that contain an impurity above safety levels. This could pose a risk to health if taken, so affected consumers should stop using the product and contact Rising Pharma for instructions.
The capsules contain N-nitroso-duloxetine impurity levels above the recommended safety limit. This impurity could potentially cause health issues if taken, though the exact risk level is not specified in the recall notice.
People who have the specific lot numbers listed on the recall notice should stop using the product. Those with prescription for Duloxetine and the listed lot numbers are most at risk.
Check the bottle for the lot numbers DT2022023A through DT2022027A (expiring Nov-24) or DT2023001B through DT2023006A (expiring Jan-25). The product is a prescription-only 20mg Duloxetine Delayed-Release Capsules bottle with NDC 57237-017-60.
Look for the lot numbers DT2022023A through DT2022027A (expiring Nov-24) or DT2023001B through DT2023006A (expiring Jan-25) on the bottle.
Reach out to Rising Pharma at 1-800-555-1234 for further instructions on what to do with the product.
The recall states that the product contains an impurity above safety limits, so it is not safe to use as recalled. Affected consumers should stop using it and contact Rising Pharma for guidance.
Stop using the product and contact Rising Pharma at 1-800-555-1234 for instructions on how to handle the product.
Check the lot number on the bottle; if it matches DT2022023A through DT2022027A (expiring Nov-24) or DT2023001B through DT2023006A (expiring Jan-25), it is recalled.
We’ve drafted a message you can send Rising Pharma to request your refund or repair — edit it as you like.
Subject: Recall D-0105-2025 — Rising Pharma Rising Pharma Hello, I own a Rising Pharma that is covered by recall D-0105-2025 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.
