Breckenridge Pharmaceutical recalls 30mg Duloxetine capsules due to potential nitrosamine impurity. Affected lots may pose health risks; contact for return instructions.
CGMP Deviations: presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the recommended interim limit.
Breckenridge Pharmaceutical is recalling 30mg Duloxetine Delayed-Release Capsules because they contain a harmful nitrosamine impurity above safety limits. This could pose health risks to people taking the medication.
The capsules contain N-nitroso-duloxetine, a nitrosamine impurity that exceeds safe levels. Nitrosamines are known carcinogens that can increase cancer risk over time.
People with prescriptions for Duloxetine 30mg 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, 30 mg, Rx Only' on the bottle. The lot number is 240909C with an expiration date of March 31, 2027.
Look for the lot number 240909C and expiration date 03/31/2027 on the bottle.
The recall record states the product contains a nitrosamine impurity above safe limits, but does not specify if it's safe to take.
The recall record does not mention any remedy or replacement options.
The recall record does not specify actions for affected consumers 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-0308-2025 — Breckenridge Breckenridge Hello, I own a Breckenridge that is covered by recall D-0308-2025 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.
