Breckenridge recalls 30mg Duloxetine Delayed-Release Capsules with N-nitroso-duloxetine impurity above FDA limits. This impurity may cause serious health risks. Consumers should contact the company for details.
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Breckenridge Pharmaceutical recalls 30mg Duloxetine Delayed-Release Capsules due to a chemical impurity that could pose serious health risks. This recall affects prescription-only bottles sold in the US. The impurity may cause harm if taken in normal use.
The capsules contain N-nitroso-duloxetine impurity levels above FDA safety limits. This impurity could potentially cause serious health issues when taken as directed. The risk is not clearly defined in the recall notice.
Prescription patients using the recalled Duloxetine capsules are affected. Those with specific health conditions may be at higher risk due to the impurity.
Check for the NDC code 51991-747-10 on the bottle label. The product was manufactured by Towa Pharmaceutical Europe, S.L. in Barcelona, Spain and distributed by Breckenridge Pharmaceuticals.
Look for the NDC code 51991-747-10 on the bottle label to confirm if it's recalled.
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 record does not mention any remedy or refund process.
The recall record does not specify actions to take for affected consumers.
We’ve drafted a message you can send Breckenridge to request your refund or repair — edit it as you like.
Subject: Recall D-0582-2026 — Breckenridge Breckenridge Hello, I own a Breckenridge that is covered by recall D-0582-2026 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.
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