Breckenridge Pharmaceutical recalls 20mg Duloxetine capsules due to potential N-nitroso impurity exceeding FDA safety limits. Affected lots may pose health risks.
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Breckenridge Pharmaceutical is recalling 20mg Duloxetine Delayed-Release Capsules from specific lots due to a chemical impurity that could exceed safe levels. This recall affects patients using prescription antidepressants who may face health risks from the impurity.
The capsules contain N-nitroso-duloxetine impurities above the FDA's interim safety limit. This impurity could potentially cause health issues if the medication is taken as prescribed, though the exact risk level isn't specified in the recall.
Prescription antidepressant users who purchased the specific lot (220128) of 20mg Duloxetine capsules from the recalled batches. Patients with depression or anxiety conditions are most at risk.
Check for the lot number 220128 on the bottle label. The product is a 20mg Duloxetine Delayed-Release Capsules, 500-count bottle with NDC 51991-746-05.
Look for the lot number 220128 on the bottle label to confirm if your product is affected.
The recall only applies to specific lots (220128) of 20mg Duloxetine capsules. Check your bottle label for the lot number to determine if your product is affected.
The recall does not specify a remedy, so contact your healthcare provider or Breckenridge Pharmaceutical for guidance on next steps.
Check the lot number on the bottle label; affected products have lot number 220128 with NDC 51991-746-05.
We’ve drafted a message you can send Breckenridge to request your refund or repair — edit it as you like.
Subject: Recall D-0009-2025 — Breckenridge Breckenridge Hello, I own a Breckenridge that is covered by recall D-0009-2025 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.
