Breckenridge Pharmaceutical recalls 60mg Duloxetine Delayed-Release Capsules due to potential N-nitroso-duloxetine impurity above FDA limits. Affected lots: NDC 82009-032-10, Lot 240539C (expiring 1/31/2027).
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
Breckenridge Pharmaceutical recalls 60mg Duloxetine Delayed-Release Capsules because they contain an impurity (N-nitroso-duloxetine) that exceeds FDA safety limits. This could pose a health risk if taken by people who need this medication.
The capsules contain N-nitroso-duloxetine impurities above the FDA's recommended safety level. This impurity could potentially cause health issues if taken by people who need this medication.
People with prescriptions for Duloxetine Delayed-Release Capsules (60mg) who received this specific batch from the manufacturer. Those who have the NDC 82009-032-10, Lot 240539C (expiring 1/31/2027) are most at risk.
Check for the NDC code 82009-032-10 and lot number 240539C on the bottle. The product expires January 31, 2027.
Look for NDC 82009-032-10 and lot number 240539C on the bottle label.
The recall indicates the product contains an impurity above FDA safety limits, so it is not safe to take.
Check for NDC 82009-032-10 and lot number 240539C on the bottle label.
The recall does not specify a remedy, so contact your healthcare provider 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-0580-2025 — Breckenridge Breckenridge Hello, I own a Breckenridge that is covered by recall D-0580-2025 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.
