Breckenridge Pharmaceuticals recalls 60mg 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 Pharmaceuticals is recalling 60mg Duloxetine Delayed-Release Capsules (NDC 51991-748-90) because they contain an impurity that could exceed FDA safety limits. This recall affects prescription-only medications sold in specific lots.
The capsules contain N-nitroso-duloxetine impurities above FDA's interim safety limit. This impurity could potentially cause health risks, though the exact risk level isn't specified in the recall notice.
Prescription patients using the recalled Duloxetine capsules (NDC 51991-748-90) are affected. Patients with depression or other conditions requiring this medication are most at risk.
Check for the product name 'Duloxetine Delayed-Release Capsules, USP, 60 mg, Rx Only, 90-count bottles' with NDC 51991-748-90. The lot number 230077C was produced and expires November 2025.
Verify the NDC code 51991-748-90 and lot number 230077C on the bottle.
The recall states the product contains an impurity above FDA's interim safety limit, but the exact health risk isn't specified.
The recall does not provide specific action steps for affected consumers.
Check the NDC code 51991-748-90 and lot number 230077C on the bottle label.
We’ve drafted a message you can send Breckenridge to request your refund or repair — edit it as you like.
Subject: Recall D-0162-2025 — Breckenridge Breckenridge Hello, I own a Breckenridge that is covered by recall D-0162-2025 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.
