Breckenridge Pharmaceuticals recalls 40mg Duloxetine capsules due to potential N-nitroso impurity above FDA limits. Affected lots may pose health risks; contact for details.
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Breckenridge Pharmaceuticals is recalling 40mg Duloxetine Delayed-Release Capsules because they contain an impurity (N-nitroso-duloxetine) that exceeds FDA safety limits. This could pose health risks to people taking the medication.
The capsules contain N-nitroso-duloxetine impurities above the FDA's interim safety limit. This impurity could potentially cause health issues, though the exact risk level is not specified in the recall.
People with prescriptions for Duloxetine 40mg capsules from the recalled lots are affected. Those with medical conditions requiring this medication are at higher risk.
Check for the product name 'Duloxetine Delayed-Release Capsules, USP, 40mg, 30-count bottles' with the lot number 230199 and expiration date 01/31/2026.
Look for the lot number 230199 and expiration date 01/31/2026 on the bottle.
The recall states the product contains impurities above FDA limits, but does not specify if it's safe to use. Consult your doctor or pharmacist.
The recall record does not mention a replacement or remedy.
The recall record does not specify actions for affected users beyond checking product details.
We’ve drafted a message you can send Breckenridge to request your refund or repair — edit it as you like.
Subject: Recall D-0511-2025 — Breckenridge Breckenridge Hello, I own a Breckenridge that is covered by recall D-0511-2025 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.
