Breckenridge recalls 30mg Duloxetine capsules (NDC 51991-747-90) due to N-nitroso-duloxetine impurity exceeding FDA limits. Affected lots may pose health risks.
CGMP Deviations: presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
Breckenridge is recalling 30mg Duloxetine Delayed-Release Capsules (90-count bottles) because they contain an impurity that exceeds FDA safety limits. This could potentially cause health risks if taken.
The capsules contain N-nitroso-duloxetine impurities above the FDA's recommended safety level. This impurity could potentially cause health issues if taken, though the exact risk level is not specified in the recall.
Prescription patients who received the specific lot number (222205C) of Duloxetine capsules from the manufacturer. Those with medical conditions requiring this medication are most at risk.
Check for the product name 'Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, 90-count bottles' with NDC 51991-747-90. The affected lot number is 222205C, expiring November 2025.
Verify the lot number on the bottle label; affected units have lot 222205C.
The recall states the product contains an impurity above FDA limits, but does not specify if it's safe to take. Consult your doctor for guidance.
The recall record does not mention a replacement or remedy for this product.
The affected lot expires November 2025.
We’ve drafted a message you can send Breckenridge to request your refund or repair — edit it as you like.
Subject: Recall D-0161-2025 — Breckenridge Breckenridge Hello, I own a Breckenridge that is covered by recall D-0161-2025 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.
