Breckenridge recalls 60mg Duloxetine Delayed-Release Capsules with N-nitroso-duloxetine impurity above FDA limits. Rx-only bottles from Towa Pharmaceuticals, lots 240947C/240962C, expiring 04/2027.
CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
Breckenridge is recalling 60mg Duloxetine Delayed-Release Capsules due to a chemical impurity that exceeds FDA safety limits. This could pose a health risk with long-term use, though the recall does not specify immediate harm.
The capsules contain N-nitroso-duloxetine impurities at levels above the FDA's recommended safety threshold. This impurity could potentially cause health issues with prolonged use, though the exact risk level is not specified in the recall.
Prescription users of Duloxetine Delayed-Release Capsules (60mg) from Towa Pharmaceuticals in Spain. Those with the specific lot numbers 240947C or 240962C are most at risk.
Check for 60mg Duloxetine Delayed-Release Capsules in 1000-count bottles with lot numbers 240947C or 240962C. These were manufactured for prescription use and expire by April 2027.
Verify the lot number on the bottle label to confirm if it matches 240947C or 240962C.
The recall states the product contains impurities above FDA limits, but does not specify immediate health risks. Consult your doctor for personalized advice.
Look for 60mg Duloxetine Delayed-Release Capsules in 1000-count bottles with lot numbers 240947C or 240962C, manufactured for prescription use.
The recall does not provide specific action steps. Check with your healthcare provider or the manufacturer 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-0215-2026 — Breckenridge Breckenridge Hello, I own a Breckenridge that is covered by recall D-0215-2026 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.
