Breckenridge Pharmaceutical recalls 60mg Duloxetine Delayed-Release Capsules due to N-nitroso-duloxetine impurity exceeding FDA limits. Affected lots manufactured in Spain, distributed in the US. Consumers should contact for remedy.
CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
Breckenridge Pharmaceutical recalled 60mg Duloxetine Delayed-Release Capsules from specific lots due to a chemical impurity that could pose health risks. This recall affects prescription medication users who purchased the affected lots.
The capsules contain N-nitroso-duloxetine impurities above the FDA's safety limit. This impurity could potentially cause health issues, though the exact risk level isn't specified in the recall notice.
Prescription medication users who purchased the recalled Duloxetine capsules from specific lots manufactured by Towa Pharmaceuticals in Spain. People with depression or other conditions treated with this medication are most at risk.
Check for the lot numbers 240534C (expires Jan 2027) or 240977C (expires Apr 2027) on the bottle. The product is a 60mg Duloxetine Delayed-Release Capsules, 1000-count bottle, prescription-only medication.
Look for the lot numbers 240534C or 240977C on the bottle label.
The recall mentions N-nitroso-duloxetine impurity above the FDA recommended limit, but does not specify the exact health risks.
Check for lot numbers 240534C (expires Jan 2027) or 240977C (expires Apr 2027) on the bottle label.
The recall record does not specify a remedy, so contact Breckenridge Pharmaceutical for further instructions.
We’ve drafted a message you can send Breckenridge to request your refund or repair — edit it as you like.
Subject: Recall D-0216-2026 — Breckenridge Breckenridge Hello, I own a Breckenridge that is covered by recall D-0216-2026 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.
