Drug FDA Class II Completed cGMP deviation

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

Torrent Pharma Inc. Published Jun 11, 2025

Risk level

Class II

May cause a temporary or reversible health problem; slight chance of serious harm.

Severity score 55/100

What should you do?

Check whether you have this product, using the lot codes, UPCs, and dates listed below.
Do not eat, serve, or sell the affected product.
Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
Contact Torrent Pharma Inc. or your place of purchase with questions, and see the source record below for full details.

Reason for recall

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

Hazards

N-Nitroso Fluoxetine · primary

Affected products (1)

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

FLUOXETINE · 3672 Bottles

NDC: 13668-443, 13668-473, 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

Lot codes: BDX6K001

Code info: Lot# BDX6K001; Exp. Date 06/30/2025

Affected areas

Nationwide

Timeline

Initiated

May 27, 2025
Published

Jun 11, 2025

Recall number: D-0455-2025
Agency: U.S. Food and Drug Administration
Country: US

Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.