Breckenridge recalls 30mg Duloxetine Delayed-Release Capsules due to potential N-nitroso impurity above FDA limits. Affected bottles have specific NDC numbers and expiration dates.
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Breckenridge Pharmaceutical recalls 30mg Duloxetine Delayed-Release Capsules that may contain an impurity above FDA safety limits. This could pose a health risk if taken as directed.
The capsules contain N-nitroso-duloxetine impurities at levels exceeding FDA's interim safety limits. This impurity could potentially cause health issues when taken as prescribed.
Prescription users of Duloxetine 30mg capsules in the recalled batches. People with depression or other conditions treated with this medication are most at risk.
Check for NDC numbers 51991-747-90 (90-count) or 51991-747-10 (1000-count) bottles. The expiration dates listed are February 2025 or November 2024.
Identify the NDC number and expiration date on the bottle to confirm if it's affected.
The recall indicates a potential impurity above FDA limits, so it's not safe to use as recalled. Consult your doctor for alternatives.
Look for NDC numbers 51991-747-90 (90-count) or 51991-747-10 (1000-count) bottles with expiration dates of February 2025 or November 2024.
The recall does not specify a remedy, so contact your doctor or pharmacist for guidance on safe alternatives.
We’ve drafted a message you can send Breckenridge to request your refund or repair — edit it as you like.
Subject: Recall D-0482-2024 — Breckenridge Breckenridge Hello, I own a Breckenridge that is covered by recall D-0482-2024 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
