Breckenridge Pharmaceutical recalls 60mg Duloxetine Delayed-Release Capsules due to nitrosamine impurity exceeding safety limits. Affected lots manufactured in 2024 with April 2027 expiration.
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
Breckenridge Pharmaceutical is recalling 60mg Duloxetine Delayed-Release Capsules bottles that contain a nitrosamine impurity above safety limits. This impurity could pose a health risk if taken by people who need this medication.
Nitrosamines are known carcinogens that can cause cancer. The presence of this impurity above safety limits in the medication could lead to health risks if taken by patients.
People with prescriptions for Duloxetine who received bottles with NDC# 51991-748-10 and lot numbers 240987C or 241014C are affected. Those taking this medication for depression, anxiety, or chronic pain are most at risk.
Check for bottles labeled 'Duloxetine Delayed-Release Capsules USP, 60 mg, 1000-count' with NDC# 51991-748-10 and lot numbers 240987C or 241014C. These were manufactured in 2024 and expire in April 2027.
Look for the NDC# 51991-748-10 and lot numbers 240987C or 241014C on the bottle.
The recall states the medication contains a nitrosamine impurity above safety limits, which could pose health risks. Do not take these specific lots.
The recall does not specify a remedy, so contact your doctor or pharmacist for guidance.
Check for the NDC# 51991-748-10 and lot numbers 240987C or 241014C 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-0387-2025 — Breckenridge Breckenridge Hello, I own a Breckenridge that is covered by recall D-0387-2025 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.
