Breckenridge recalls 30mg Duloxetine Delayed-Release Capsules with N-nitroso impurity above FDA limits. Affected lots: 240225C (exp 01/2027). Stop using immediately if you have these capsules.
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
Breckenridge Pharmaceutical recalls 30mg Duloxetine Delayed-Release Capsules from specific lots due to a chemical impurity that could pose health risks. This recall affects prescription-only bottles sold in the U.S. and requires immediate action to avoid potential health issues.
The capsules contain N-nitroso-duloxetine impurities at levels above the FDA's interim safety limit. This impurity could potentially cause health risks when taken as prescribed, though the exact risk level isn't specified in the recall.
Prescription patients who have the specific lot number (240225C) of Duloxetine Delayed-Release Capsules (30mg, 1000-count bottles) from the manufacturer. Those with the product are at risk of health issues due to the impurity.
Check for the lot number 240225C on the bottle label. The product is a 30mg Duloxetine Delayed-Release Capsules, 1000-count bottle with NDC 51991-747-10, manufactured in Barcelona, Spain and distributed by Breckenridge Pharmaceuticals.
Immediately stop using the recalled Duloxetine Delayed-Release Capsules with lot number 240225C.
The recalled lot number is 240225C (expiration date 01/2027).
Check for the lot number 240225C on the bottle label. The product is a 30mg Duloxetine Delayed-Release Capsules, 1000-count bottle with NDC 51991-747-10, manufactured in Barcelona, Spain and distributed by Breckenridge Pharmaceuticals.
The recall record states the remedy is null, meaning no specific remedy is provided beyond stopping use.
We’ve drafted a message you can send Breckenridge to request your refund or repair — edit it as you like.
Subject: Recall D-0270-2025 — Breckenridge Breckenridge Hello, I own a Breckenridge that is covered by recall D-0270-2025 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.
