Torrent Pharma recalls 20mg Fluoxetine tablets due to potential safety risk from N-Nitroso Fluoxetine exceeding acceptable intake limits. Consumers should stop using affected lots.
CGMP Deviations: Presence of N-Nitroso Fluoxetine exceeding interim acceptable intake limit.
Torrent Pharma is recalling 20mg Fluoxetine tablets that may contain unsafe levels of N-Nitroso Fluoxetine. This could pose a health risk if taken regularly, so affected consumers should stop using the product immediately.
The tablets may contain N-Nitroso Fluoxetine in amounts exceeding the interim acceptable intake limit. This chemical has been linked to potential health risks, including possible harm to the liver and other organs when taken over time.
People who have purchased the 20mg Fluoxetine tablets from Torrent Pharma in the US. Those taking this medication for depression or anxiety are most at risk.
Check the product label for the NDC code 13668-473-91 (carton) or 13668-473-70 (blister). The lot number BDX6K001 and expiration date 06/30/2025 are also on the packaging.
Immediately stop using the recalled Fluoxetine tablets if you have them.
The tablets may contain N-Nitroso Fluoxetine in amounts exceeding the interim acceptable intake limit, which could pose health risks.
Look for the NDC code 13668-473-91 (carton) or 13668-473-70 (blister), lot number BDX6K001, and expiration date 06/30/2025 on the packaging.
Stop using the product immediately and contact Torrent Pharma for further instructions.
We’ve drafted a message you can send Torrent to request your refund or repair — edit it as you like.
Subject: Recall D-0456-2025 — Torrent Torrent Hello, I own a Torrent that is covered by recall D-0456-2025 from Torrent. 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.
