Breckenridge Pharmaceuticals recalls 60mg Duloxetine Delayed-Release Capsules due to N-nitroso-duloxetine impurity exceeding safety limits. Affected lots manufactured in Spain, distributed in the US. No specific remedy stated in official notice.
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above safety assessment limit
Breckenridge Pharmaceuticals is recalling 60mg Duloxetine Delayed-Release Capsules because they contain an impurity (N-nitroso-duloxetine) that exceeds safe levels. This could pose a health risk to people taking the medication as prescribed.
The capsules contain an impurity called N-nitroso-duloxetine that exceeds the safety assessment limit. This impurity could potentially cause health issues when taken as directed by a doctor.
People who have been prescribed Duloxetine Delayed-Release Capsules 60mg, 1,000-count bottles from the manufacturer. Those with specific medical conditions requiring this medication are most at risk.
Check for the product name 'Duloxetine Delayed-Release Capsules, USP, 60mg', 1,000-count bottles. Look for the lot number 230836C and expiration date 02/28/2026 on the packaging.
Verify the product name, lot number, and expiration date on the packaging to confirm if it's affected.
The official recall notice states the product contains an impurity exceeding safety limits, but does not specify if it's safe to take. Consult your doctor for medical advice.
The recall notice does not provide specific action steps for affected products. Check with your doctor or the manufacturer for guidance.
Look for the lot number 230836C and expiration date 02/28/2026 on the packaging. The product name is 'Duloxetine Delayed-Release Capsules, USP, 60mg', 1,000-count bottles.
We’ve drafted a message you can send Breckenridge to request your refund or repair — edit it as you like.
Subject: Recall D-0552-2025 — Breckenridge Breckenridge Hello, I own a Breckenridge that is covered by recall D-0552-2025 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.
