The Harvard Drug Group, doing business as Major Pharmaceuticals, is recalling Duloxetine (duloxetine) Delayed-Release Capsules USP, 20 mg. Approximately a) 6408 boxes and b) 1488 boxes are affected by this recall. The medication is being recalled because it contains levels of N-Nitroso-Duloxetine, a nitrosamine impurity, that exceed the FDA's recommended acceptable intake limit. This drug is used to treat depression, anxiety, and certain types of chronic pain.
Nitrosamines are chemicals that are classified as probable human carcinogens. While everyone is exposed to some nitrosamines in food and water, exposure above acceptable levels over long periods of time may increase the risk of cancer.
You have 2 options:
Packaged in 3x10 blister packs.
Packaged in 10x10 blister packs.
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.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
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