The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0456-2025·Announced 2025-06-11

Fluoxetine Tablets 20 mg Recalled for N-Nitroso Impurity

Torrent Pharma Inc. is recalling Fluoxetine Tablets, USP, 20 mg in a 28-count carton due to the presence of N-Nitroso Fluoxetine exceeding the interim acceptable intake limit.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: This is an FDA Class II recall involving a prescription drug with a known impurity (N-Nitroso Fluoxetine) exceeding acceptable limits. Although no illnesses have been reported, the source does not state that no harm has been reported; the presence of an impurity exceeding interim acceptable intake limits in a widely distributed psychiatric medication meets the Severe threshold under the rubric for Class II drug recalls.

Plain-English summary

Torrent Pharma Inc. is recalling Fluoxetine Tablets, USP, 20 mg (NDC: 13668-473-91 for carton; 13668-473-70 for blister) due to CGMP deviations involving the presence of N-Nitroso Fluoxetine that exceeds the interim acceptable intake limit.

The affected product is a 28-count carton in a 4x7 unit-dose configuration manufactured by Torrent Pharmaceuticals Ltd. in Indrad, India, for Torrent Pharma Inc., Basking Ridge, New Jersey. The recall involves Lot# BDX6K001 with an expiration date of 06/30/2025, totaling 972 cartons distributed nationwide in the United States.

Patients currently taking this medication should not stop taking it without consulting their healthcare provider. Patients should contact their healthcare provider or pharmacist regarding this recall and disposal of any affected product they may have.

The recalled product

Product
FLUOXETINE (FLUOXETINE)
Brand
FLUOXETINE
Manufacturer
Torrent Pharma Inc.
Category
Drug — Prescription Antidepressant
Hazard
Affected units
972

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.

Part of a larger recall action

This product is one of 2 recalled by Torrent Pharma Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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Same hazard · n nitroso impurity

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