Breckenridge Pharmaceutical recalls 20mg Duloxetine capsules due to potential N-nitroso impurity exceeding FDA safety limits. Affected bottles have NDC 51991-746-05 and expire Feb 2025.
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Breckenridge Pharmaceutical is recalling 20mg Duloxetine Delayed-Release Capsules in 500-count bottles because they contain an impurity (N-nitroso-duloxetine) that exceeds FDA safety limits. This could pose a health risk if taken as directed.
The capsules contain N-nitroso-duloxetine impurities above the FDA's interim safety limit. This impurity could potentially cause health issues if taken as directed, though the risk level is considered low by the manufacturer.
Prescription patients who have the 500-count bottles with NDC 51991-746-05. Those taking Duloxetine for depression or nerve pain are most at risk.
Check for the NDC code 51991-746-05 on the bottle. The product is a 20mg Duloxetine Delayed-Release Capsules, 500-count bottle, prescription-only, with an expiration date of February 2025.
Look for the NDC code 51991-746-05 on the bottle label to confirm it's affected.
The manufacturer states the impurity level is below the FDA's interim safety limit, but the product is being recalled due to potential health risks.
Check for the NDC code 51991-746-05 on the bottle label. The product is a 20mg Duloxetine Delayed-Release Capsules, 500-count bottle with an expiration date of February 2025.
The recall record does not specify a remedy, so contact your doctor or pharmacist for guidance.
We’ve drafted a message you can send Breckenridge to request your refund or repair — edit it as you like.
Subject: Recall D-0483-2024 — Breckenridge Breckenridge Hello, I own a Breckenridge that is covered by recall D-0483-2024 from Breckenridge. 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.
