Breckenridge recalls 20mg Duloxetine capsules with N-nitroso impurity above FDA limits. Stop using if you have affected lots. Details: NDC 51991-746-05, Lot 240098C.
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
Breckenridge Pharmaceutical recalls 20mg Duloxetine Delayed-Release Capsules due to a chemical impurity that could pose health risks. This recall affects specific batches made in Spain and distributed in the U.S. The impurity level exceeds FDA safety thresholds, requiring immediate action.
The recall involves a chemical impurity called N-nitroso-duloxetine that exceeds FDA safety limits. This impurity could potentially cause health issues, though the exact risk level is not specified in the recall notice.
People with prescriptions for Duloxetine 20mg capsules from the recalled batches (NDC 51991-746-05, Lot 240098C) are affected. Those using the product without a prescription are not at risk.
Check for the NDC code 51991-746-05 and lot number 240098C on the bottle. The product was manufactured in Martorelles, Barcelona, Spain, and distributed by Breckenridge Pharmaceuticals in the U.S.
Look for the NDC code 51991-746-05 and lot number 240098C on the bottle label.
The recall states the product has an impurity above FDA limits, but the exact health risk is not specified. Do not use if you have the recalled batch.
Check for NDC 51991-746-05 and lot number 240098C on the bottle label. The product was manufactured in Spain and distributed by Breckenridge Pharmaceuticals.
The recall does not specify a remedy, so contact Breckenridge Pharmaceuticals 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-0271-2025 — Breckenridge Breckenridge Hello, I own a Breckenridge that is covered by recall D-0271-2025 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.
