Breckenridge Pharmaceutical recalls 60mg Duloxetine capsules due to N-nitroso-duloxetine impurity exceeding FDA limits. Affected lots: 241069C (exp 05/31/2027).
CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
Breckenridge Pharmaceutical is recalling 60mg Duloxetine Delayed-Release Capsules because they contain an impurity (N-nitroso-duloxetine) above FDA safety limits. This could pose a health risk to people taking the medication.
The capsules contain N-nitroso-duloxetine impurities at levels above the FDA's recommended safety limit. This impurity could potentially cause health issues, though the exact risk level isn't specified in the recall notice.
People who have the specific lot number 241069C of the 60mg Duloxetine capsules (90-count bottle) from Breckenridge Pharmaceutical. Those taking this medication for depression or nerve pain are most at risk.
Check for the lot number 241069C on the bottle label. The product is a 60mg Duloxetine Delayed-Release Capsules USP, 90-count bottle manufactured by Towa Pharmaceutical in Spain and distributed by Breckenridge Pharmaceutical.
Look for the lot number 241069C on the bottle label to confirm if it's affected.
The recall states the product contains an impurity above FDA limits, but does not specify if it's safe to use. The manufacturer has not provided a remedy.
The recall does not specify any action steps. You should check the product label for the lot number 241069C and contact your healthcare provider for advice.
Check the product label for the lot number 241069C. The product is a 60mg Duloxetine Delayed-Release Capsules USP, 90-count bottle manufactured by Towa Pharmaceutical in Spain and distributed by Breckenridge Pharmaceutical.
We’ve drafted a message you can send Breckenridge Pharmaceutical to request your refund or repair — edit it as you like.
Subject: Recall D-0522-2026 — Breckenridge Pharmaceutical Breckenridge Pharmaceutical Hello, I own a Breckenridge Pharmaceutical that is covered by recall D-0522-2026 from Breckenridge Pharmaceutical. 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.
