The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-0455-2025·Announced 2025-06-11

Fluoxetine Tablets USP 20 mg Recalled for N-Nitroso Contamination

Torrent Pharma Inc. is recalling Fluoxetine Tablets USP 20 mg due to the presence of N-Nitroso Fluoxetine exceeding the interim acceptable intake limit. The affected lot is distributed nationwide.

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 3/5 (High).

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: The FDA classified this as a Class II recall for a contamination issue (N-Nitroso Fluoxetine exceeding acceptable intake limits). No reported illnesses or injuries are stated in the source. The hazard involves potential carcinogenic impurity, which qualifies as a risk-of-harm product without reported adverse health events, supporting a score of 3 per the rubric.

Plain-English summary

Torrent Pharma Inc. is recalling Fluoxetine Tablets, USP, 20 mg in 30-count bottles (NDC 13668-473-30, Lot# BDX6K001, expiration date 06/30/2025) manufactured by Torrent Pharmaceuticals Ltd. in India. The recall affects approximately 3,672 bottles distributed nationwide in the United States.

The recall is due to the presence of N-Nitroso Fluoxetine in the product that exceeds the interim acceptable intake limit established by the FDA. This represents a deviation from current good manufacturing practice (CGMP) standards.

Patients currently taking this medication should not stop taking their fluoxetine without consulting their healthcare provider. Consumers with this product should contact their pharmacy or healthcare provider regarding the recall. Healthcare providers and patients with questions may contact Torrent Pharma Inc. or the FDA for additional information.

The recalled product

Product
FLUOXETINE (FLUOXETINE)
Brand
FLUOXETINE
Manufacturer
Torrent Pharma Inc.
Category
Drug — Oral Prescription Medication
Hazard
Affected units
3,672

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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