# FDA recall D-0455-2025

> **Torrent Pharma Inc.** · Class II · drug recall initiated 2025-05-27.

## Product

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

## Reason for recall

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

## Distribution

U.S. Nationwide.

## Key facts

- **Recall number:** D-0455-2025
- **Recalling firm:** Torrent Pharma Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2025-05-27
- **Report date:** 2025-06-11

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Basking Ridge, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0455-2025

## Citation

> AI Analytics. FDA recall D-0455-2025. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/D-0455-2025. Source: US FDA. Licensed CC0.

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