Breckenridge Pharmaceutical recalls 60mg Duloxetine Delayed-Release Capsules due to N-nitroso-duloxetine impurity exceeding safety limits. Affected products include 90-count (NDC 51991-748-90) and 1000-count (NDC 51991-748-10) bottles. No remedy specified in recall notice.
CGMP Deviations: N-nitroso-duloxetine impurity above the safety assessment limit of 12.5ppm.
Breckenridge Pharmaceutical is recalling 60mg Duloxetine Delayed-Release Capsules because they contain an impurity (N-nitroso-duloxetine) at levels above the safety limit. This could pose a risk to health, though the exact harm isn't specified in the recall notice.
The capsules contain an impurity called N-nitroso-duloxetine at levels above the safety assessment limit of 12.5 parts per million. This impurity could potentially cause health issues, though the exact risk is not clearly described in the recall notice.
People who have the 90-count or 1000-count bottles of Duloxetine Delayed-Release Capsules (NDC 51991-748-90 or 51991-748-10) prescribed by a doctor. Those with the specific lot numbers and expiration dates listed in the recall notice are most at risk.
Check for the 90-count bottle (NDC 51991-748-90) or 1000-count bottle (NDC 51991-748-10) with the lot numbers and expiration dates listed in the recall notice. The product is prescription-only and distributed by Breckenridge Pharmaceutical, Inc.
Identify if you have the 90-count or 1000-count bottles of Duloxetine Delayed-Release Capsules with the specific NDC numbers and lot numbers mentioned in the recall notice.
The recall notice does not specify any remedy or action to take.
The product contains N-nitroso-duloxetine impurity at levels above the safety assessment limit of 12.5ppm.
The affected products are 90-count bottles (NDC 51991-748-90) and 1000-count bottles (NDC 51991-748-10) of Duloxetine Delayed-Release Capsules.
We’ve drafted a message you can send Breckenridge Pharmaceutical to request your refund or repair — edit it as you like.
Subject: Recall D-0100-2026 — Breckenridge Pharmaceutical Breckenridge Pharmaceutical Hello, I own a Breckenridge Pharmaceutical that is covered by recall D-0100-2026 from Breckenridge Pharmaceutical. 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.
