Breckenridge recalls 60mg Duloxetine Delayed-Release Capsules with N-nitroso-duloxetine impurity above FDA limits. Stop using affected lots to avoid potential health risks.
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
Breckenridge Pharmaceutical recalls 60mg Duloxetine Delayed-Release Capsules due to a chemical impurity that may pose health risks. This recall affects specific lots manufactured in Spain and distributed in the US. The impurity could cause health issues if taken in normal use.
The product contains N-nitroso-duloxetine impurity levels above the FDA's recommended safety limit. This impurity could potentially cause health issues when taken as directed. The risk is not clearly described in the recall notice.
People who have the specific 60mg Duloxetine Delayed-Release Capsules with NDC 51991-748-10 and lot number 240301C are affected. Those using prescription antidepressants may be at higher risk.
Check for the NDC code 51991-748-10 and lot number 240301C on the bottle. The product was manufactured in Martorelles, Barcelona, Spain and distributed by Breckenridge Pharmaceuticals in the US.
Look for the NDC code 51991-748-10 and lot number 240301C on the bottle label.
The recall states the product contains N-nitroso-duloxetine impurity above FDA limits, but does not specify if it's safe to use.
The recall does not provide a remedy, so no specific action is required beyond checking product details.
Check for the NDC code 51991-748-10 and lot number 240301C on the bottle label.
We’ve drafted a message you can send Breckenridge to request your refund or repair — edit it as you like.
Subject: Recall D-0269-2025 — Breckenridge Breckenridge Hello, I own a Breckenridge that is covered by recall D-0269-2025 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.
