Breckenridge Pharmaceutical recalls 60mg Duloxetine capsules due to potential N-nitroso impurity above FDA limits. Affected lots: 230035C (exp 11/30/2025) and 230101C (exp 12/31/2025).
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, though the specific danger isn't detailed in the recall.
The capsules contain N-nitroso-duloxetine impurities above the FDA's recommended safety level. This impurity could potentially cause health issues, but the exact risk isn't specified in the recall notice.
People with prescriptions for Duloxetine who bought the recalled 60mg capsules from the listed lots. Those taking the medication for depression or nerve pain are most at risk.
Check the product label for the NDC code 51991-748-90 and lot numbers 230035C (expires 11/30/2025) or 230101C (expires 12/31/2025).
Look for the NDC code 51991-748-90 and lot numbers 230035C or 230101C on the bottle.
The recall states the impurity exceeds FDA safety limits but does not specify the exact health risk.
Check the product label for NDC 51991-748-90 and lot numbers 230035C (expires 11/30/2025) or 230101C (expires 12/31/2025).
The recall does not specify a stop-use instruction, so you should check the product label first.
We’ve drafted a message you can send Breckenridge to request your refund or repair — edit it as you like.
Subject: Recall D-0562-2024 — Breckenridge Breckenridge Hello, I own a Breckenridge that is covered by recall D-0562-2024 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.
