Torrent Pharma Fluoxetine Tablets Recall: FDA Class II

Why it was recalled

CGMP Deviations: Presence of N-Nitroso Fluoxetine exceeding interim acceptable intake limit.

Product description

Fluoxetine Tablets, USP, 20 mg, 30-count bottle, Rx only, Manufactured by: TORRENT PHARMACEUTIALS LTD., Indrad-382 721 INDIA; Manufactured for: TORRENT PHARMA INC., Basking Ridge, NJ 07920. NDC: 13668-473-30

Lot numbers, UPCs & expiration codes

Lot# BDX6K001; Exp. Date 06/30/2025

Where it was sold

U.S. Nationwide.

What to do if you have this product

Compare the lot number and expiration date on your package with the codes above.
Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
If you have symptoms you think are related, contact your doctor. In an emergency call 911.
Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number: D-0455-2025
Classification: Class II
Status: Completed
Recall initiated: May 27, 2025
FDA report date: Jun 11, 2025
Quantity: 3672 Bottles
Recall type: Voluntary: Firm initiated
Recalling firm: Torrent Pharma Inc.

Original FDA data

Every field from FDA enforcement report D-0455-2025, exactly as published.

Show all FDA fields

City: Basking Ridge
State: NJ
Status: Completed
Country: United States
Event ID: 96983
Address: 106 Allen Rd Ste 305
Code information: Lot# BDX6K001; Exp. Date 06/30/2025
Postal code: 07920-3851
Report date: Jun 11, 2025
Product type: Drugs
Recall number: D-0455-2025
Classification: Class II
Recalling firm: Torrent Pharma Inc.
Product quantity: 3672 Bottles
Reason for recall: CGMP Deviations: Presence of N-Nitroso Fluoxetine exceeding interim acceptable intake limit.
Voluntary / mandated: Voluntary: Firm initiated
Product description: Fluoxetine Tablets, USP, 20 mg, 30-count bottle, Rx only, Manufactured by: TORRENT PHARMACEUTIALS LTD., Indrad-382 721 INDIA; Manufactured for: TORRENT PHARMA INC., Basking Ridge, NJ 07920. NDC: 13668-473-30
Distribution pattern: U.S. Nationwide.
Recall initiation date: May 27, 2025
Initial firm notification: E-Mail
Center classification date: Jun 2, 2025

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0455-2025, published Jun 11, 2025. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: Oct 2, 2026. Content last changed: Oct 2, 2026.

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

Torrent Pharma Fluoxetine Tablets Recall

Summary