Torrent Pharma Inc. is recalling 4,644 units of Fluoxetine (fluoxetine) Tablets, 20 mg, including 30-count bottles and 28-count unit-dose cartons. The recall was issued because tests found levels of N-Nitroso Fluoxetine, a nitrosamine impurity, that exceed the FDA's interim acceptable intake limit. Consumers are advised to consult their healthcare provider or pharmacist regarding their prescription and should not stop taking their medication without medical guidance.
N-Nitroso Fluoxetine is a nitrosamine impurity that may increase the risk of cancer if individuals are exposed to it above acceptable levels over a long period of time. No reports of injuries or adverse events have been linked to this recall.
You have 2 options:
Rx only; Manufactured for: Torrent Pharma Inc.
NDC 13668-473-91 refers to the Carton; 13668-473-70 refers to the Blister.
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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