Prescription Fluoxetine tablets recalled for N-nitroso manufacturing defect
Torrent Pharma Inc. is recalling Fluoxetine 20 mg tablets distributed nationwide due to Current Good Manufacturing Practice deviations resulting in N-nitroso impurity exceeding the FDA's interim acceptable intake limit.
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 for a manufacturing defect resulting in N-nitroso impurity exceeding the interim acceptable intake limit, representing a risk-of-harm product.
Plain-English summary
Torrent Pharma Inc. is recalling Fluoxetine Tablets, USP, 20 mg distributed nationwide. The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations that resulted in the presence of N-nitroso Fluoxetine exceeding the FDA's interim acceptable intake limit.
The affected product is Lot# BDX6K001 with expiration date 06/30/2025 (NDC 13668-473-30). A total of 3,672 bottles have been distributed in the United States.
Consumers with the affected product should contact their pharmacy or healthcare provider for guidance on obtaining a replacement or alternative medication. Patients should not stop taking their medication without consulting their healthcare provider.
The recalled product
- Product
- FLUOXETINE (FLUOXETINE)
- Brand
- FLUOXETINE
- Manufacturer
- Torrent Pharma Inc.
- Category
- Drug — Antidepressant
- Hazard
- n-nitroso-impurity
- manufacturing-defect
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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