Breckenridge Pharmaceutical recalls 30mg Duloxetine capsules due to N-nitroso-duloxetine impurity exceeding safety limits. Affected lots manufactured in Spain for US distribution.
CGMP deviations: N-nitroso-duloxetine impurity above the proposed interim limit.
Breckenridge Pharmaceutical is recalling 30mg Duloxetine Delayed-Release Capsules because they contain an impurity (N-nitroso-duloxetine) that exceeds safety limits. This could pose a health risk to people taking the medication.
The capsules contain an impurity called N-nitroso-duloxetine that exceeds the safety limit set by the manufacturer. This impurity could potentially cause health issues when taken by people who need the medication.
People with prescriptions for Duloxetine 30mg capsules who received this specific batch from the manufacturer. Those taking the medication for depression or nerve pain are most at risk.
Check for the NDC code 82009-030-10 and lot number 240927C on the bottle. The capsules were manufactured in Spain and distributed for US use with an expiration date of April 30, 2027.
Look for the NDC code 82009-030-10 and lot number 240927C on the bottle label.
The official recall notice states the product contains an impurity above safety limits, so it is not safe to take.
Check for the NDC code 82009-030-10 and lot number 240927C on the bottle label.
The recall notice does not specify a remedy, so you should contact 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-0621-2025 — Breckenridge Breckenridge Hello, I own a Breckenridge that is covered by recall D-0621-2025 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.
