Stop using now Drug recall · FDA · Published May 27, 2025

Torrent Fluoxetine Tablets 20mg Recall: N-Nitroso Fluoxetine Exceeds Safety Limits

Torrent Pharma recalls 20mg Fluoxetine tablets due to potential safety risk from N-Nitroso Fluoxetine exceeding acceptable intake limits. Consumers should stop using affected lots.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-0456-2025Drug Torrent ›

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

Take action

Contact the company

Recalling firmTorrent Pharma Inc.106 Allen Rd Ste 305 · Basking Ridge, NJ 07920-3851

✎ GovInfoNow plain-language explainer

Torrent Pharma is recalling 20mg Fluoxetine tablets that may contain unsafe levels of N-Nitroso Fluoxetine. This could pose a health risk if taken regularly, so affected consumers should stop using the product immediately. Read more at govinfonow.com/recall/32050-torrent-fluoxetine-tablets-20mg-recall-n-nitroso-fluoxetine-exceeds-safety.

Source Summary by GovInfoNow · govinfonow.com/recall/32050-torrent-fluoxetine-tablets-20mg-recall-n-nitroso-fluoxetine-exceeds-safety · Updated August 18, 2026 · FDA enforcement record: FDA #D-0456-2025

Cite this page

“Torrent Fluoxetine Tablets 20mg Recall: N-Nitroso Fluoxetine Exceeds Safety Limits.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/32050-torrent-fluoxetine-tablets-20mg-recall-n-nitroso-fluoxetine-exceeds-safety. Based on FDA recall #D-0456-2025 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0456-2025%22&limit=1).

Torrent Pharma Inc. recalled Fluoxetine Tablets, USP, 20 mg, 28-count Cartons nationwide on May 27, 2025, due to CGMP deviations involving N-Nitroso Fluoxetine levels exceeding the interim acceptable intake limit, the FDA said.

How to tell if you have it

Brand: Torrent
Product: Fluoxetine Tablets, USP, 20 mg, 28-count Carton (4x7 Unit-dose)
Manufacturer: TORRENT PHARMACEUTIALS LTD., Indrad-382 721 INDIA
NDC: 13668-473-91 (Carton); 13668-473-70 (Blister)
Lot#: BDX6K001
Exp. Date: 06/30/2025
Quantity: 972 Cartons

The hazard

The recall addresses CGMP deviations where the presence of N-Nitroso Fluoxetine exceeded the interim acceptable intake limit, according to the FDA.

Context

GovInfoNow's records show Torrent Pharma Inc. has 14 other recalls on record since July 22, 2013. Other recent recalls of similar products include Torrent Pantoprazole Tablets Recall (April 11, 2022), Torrent Pharma recalls 200mg Carbamazepine tablets (Dec. 2, 2021), and Torrent Telmisartan/Hydrochlorothiazide Tablets Recall (Dec. 1, 2021). Other recent recalls of similar products include Asclemed Duloxetine Capsules Recall (May 14, 2026), Breckenridge Duloxetine Capsules Recall (April 21, 2026), and Breckenridge Duloxetine Capsules Recall (June 4, 2026).

How to tell if you have this one

Check the product label for the NDC code 13668-473-91 (carton) or 13668-473-70 (blister). The lot number BDX6K001 and expiration date 06/30/2025 are also on the packaging.

Brand
Torrent
Category
Drug

FDA recall event · 2 products

All 2 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Completed
Distribution
U.S. Nationwide.

Recall number	Product, codes & lots	Quantity	NDC
D-0455-2025	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# BDX6K001; Exp. Date 06/30/2025	3672 Bottles	13668-443-74, 13668-443-10, 13668-443-01, 13668-443-30, 13668-443-91, 13668-473-10, 13668-473-74, 13668-473-30, 13668-473-01, 13668-473-91
D-0456-2025	Fluoxetine Tablets, USP, 20 mg, 28-count Carton (4x7 Unit-dose), Manufactured by: TORRENT PHARMACEUTIALS LTD., Indrad-382 721 INDIA; Manufactured for: TORRENT PHARMA INC., Basking Ridge, NJ 07920. NDC: 13668-473-91 (Carton); 13668-473-70 (Blister); Lot# BDX6K001; Exp. Date: 06/30/2025	972 Cartons	13668-443-74, 13668-443-10, 13668-443-01, 13668-443-30, 13668-443-91, 13668-473-10, 13668-473-74, 13668-473-30, 13668-473-01, 13668-473-91, 13668-473-70

Based on the official FDA remedy

What to do — step by step

Stop Using Now
Immediately stop using the recalled Fluoxetine tablets if you have them.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “U.S. Nationwide.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA published this recall 15 days after the firm started it.

May 27, 2025Firm started the recall
Jun 2, 2025FDA classified it Class II
Jun 11, 2025Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/32050-torrent-fluoxetine-tablets-20mg-recall-n-nitroso-fluoxetine-exceeds-safety">Torrent Fluoxetine Tablets 20mg Recall: N-Nitroso Fluoxetine Exceeds Safety Limits (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #D-0456-2025 (May 27, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0456-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.