Fluoxetine tablets recalled due to excess N-Nitroso contaminant
Torrent Pharma Inc. is recalling 972 cartons of Fluoxetine 20 mg tablets nationwide due to manufacturing deviations resulting in N-Nitroso Fluoxetine exceeding acceptable intake limits. Patients should contact their healthcare provider or pharmacist.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall with no reported illnesses or injuries in the source material. Classified as High per rubric criterion for risk-of-harm products where injury has not yet been reported, as the presence of N-nitroso impurity exceeding acceptable limits poses a potential health concern.
Plain-English summary
Torrent Pharma Inc. is recalling Fluoxetine Tablets, USP, 20 mg in 28-count cartons (lot BDX6K001, expiration date 06/30/2025). The recall affects 972 cartons distributed nationwide in the United States.
The recall was initiated due to manufacturing deviations discovered during quality control processes. Testing identified the presence of N-Nitroso Fluoxetine in the affected product exceeding the interim acceptable intake limit established by the Food and Drug Administration for this impurity.
Patients or healthcare providers who have dispensed or received medication from lot BDX6K001 are advised to contact Torrent Pharma Inc. or their healthcare provider for further guidance regarding the affected product.
The recalled product
- Product
- FLUOXETINE (FLUOXETINE)
- Brand
- FLUOXETINE
- Manufacturer
- Torrent Pharma Inc.
- Category
- Drug
- Hazard
- n-nitroso-impurity
- manufacturing-deviation
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot# BDX6K001
- Exp. Date: 06/30/2025
UPCs (2)
- 0313668443301
- 0313668473308
Distribution
Distributed nationwide across the United States.
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