Breckenridge Pharmaceutical, Inc. is recalling approximately 240,851 bottles of Duloxetine (duloxetine) Delayed-Release Capsules because they were found to contain levels of N-nitroso-duloxetine that exceed the FDA's recommended interim limits. The recall affects 90-count bottles of both 30mg and 60mg strengths distributed nationwide. Consumers who take this medication for depression, anxiety, or nerve pain should consult their doctor before stopping treatment, as suddenly stopping can lead to side effects.
N-nitroso-duloxetine is a nitrosamine impurity that may increase the risk of cancer if people are exposed to it above acceptable levels over long periods of time. While there is no immediate acute risk, the impurity levels in these specific lots were found to be higher than what the FDA considers acceptable for daily use.
You have 2 options:
Recall #: D-0161-2025; Quantity: 163,883 bottles
Recall #: D-0162-2025; Quantity: 76,968 bottles
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
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Sources: FDA iRES · Raw API Response
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