Breckenridge Pharmaceutical recalls 60mg Duloxetine Delayed-Release Capsules due to N-nitroso-duloxetine impurity exceeding FDA limits. Rx-only medication with specific lot numbers and expiration dates.
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Breckenridge Pharmaceutical is recalling 60mg Duloxetine Delayed-Release Capsules because they contain an impurity (N-nitroso-duloxetine) that exceeds FDA safety limits. This could pose a health risk to people taking the medication.
The medication contains N-nitroso-duloxetine impurities above the FDA's recommended safety level. This impurity could potentially cause health issues, though the exact risk level isn't specified in the recall notice.
People with prescriptions for Duloxetine Delayed-Release Capsules (60mg) from the recalled lots. Those who have taken the medication without medical supervision are at risk.
Check for the product name 'Duloxetine Delayed-Release Capsules, USP, 60mg' with specific lot numbers: 241074C (exp. May 2027), 240317-240375C (exp. Feb 2027), 240316 (exp. Jan 2027), 232311 (exp. Nov 2026), or 240978C (exp. Apr 2027).
Identify the lot number and expiration date on the packaging to determine if your medication is recalled.
The recall states the medication contains an impurity above FDA limits, but the exact health risk isn't specified. Do not take the medication without consulting a healthcare provider.
Contact your healthcare provider for guidance on whether to stop taking the medication and how to proceed with the recall.
Yes, avoid the recalled lots: 241074C (exp. May 2027), 240317-240375C (exp. Feb 2027), 240316 (exp. Jan 2027), 232311 (exp. Nov 2026), and 240978C (exp. Apr 2027).
We’ve drafted a message you can send Breckenridge to request your refund or repair — edit it as you like.
Subject: Recall D-0583-2026 — Breckenridge Breckenridge Hello, I own a Breckenridge that is covered by recall D-0583-2026 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.
