Torrent Pharma recalls 20mg Fluoxetine tablets due to N-Nitroso Fluoxetine exceeding safety limits. Affected products have NDC 13668-473-30, lot BDX6K001, expiring June 2025. Consumers should contact the company for details.
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 chemical exceeds safety limits and could pose health risks. The recall affects specific batches sold in the U.S. with a particular expiration date.
The tablets contain N-Nitroso Fluoxetine, a chemical that exceeds the interim acceptable intake limit set by regulatory standards. This could lead to potential health risks, though the exact impact is not specified in the recall notice.
People who have the specific 20mg Fluoxetine tablets with NDC 13668-473-30, lot BDX6K001, expiring June 2025. Those using prescription antidepressants are most at risk.
Check for the NDC code 13668-473-30, lot number BDX6K001, and expiration date of June 30, 2025. The product is a prescription-only 20mg Fluoxetine tablet bottle.
Look for the NDC code 13668-473-30, lot number BDX6K001, and expiration date of June 30, 2025 on the bottle.
The recall states the product may contain unsafe levels of N-Nitroso Fluoxetine, so it is not recommended for use until the remedy is applied.
Check for the NDC code 13668-473-30, lot number BDX6K001, and expiration date of June 30, 2025 on the bottle.
The recall does not specify a remedy, so 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-0455-2025 — Torrent Torrent Hello, I own a Torrent that is covered by recall D-0455-2025 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.
