FDA Drug recall D-0455-2025
Fluoxetine Tablets, USP, 20 mg, 30-count bottle, Rx only, Manufactured by: TORRENT PHARMACEUTIALS LTD., Indrad-382 721 INDIA
- FDA Drug
- Class II
- completed
- Published 2025-06-11
On 2025-06-11 the FDA classified a Class II recall of Fluoxetine Tablets, USP, 20 mg, 30-count bottle, Rx only, Manufactured by: TORRENT PHARMACEUTIALS LTD., Indrad-382 721 INDIA by Torrent Pharma, citing CGMP Deviations: Presence of N-Nitroso Fluoxetine exceeding interim acceptable intake limit.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0455-2025 |
| Classification | Class II |
| Status | completed |
| Initiated | 2025-05-27 |
| Published | 2025-06-11 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Torrent Pharma |
| Distribution | US |
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
CGMP Deviations: Presence of N-Nitroso Fluoxetine exceeding interim acceptable intake limit.
Identifiers
| ndc | 13668-443-74 |
|---|---|
| ndc | 13668-443-10 |
| ndc | 13668-443-01 |
| ndc | 13668-443-30 |
| ndc | 13668-443-91 |
| ndc | 13668-473-10 |
| ndc | 13668-473-74 |
| ndc | 13668-473-30 |
| ndc | 13668-473-01 |
| ndc | 13668-473-91 |
| code_info | Lot# BDX6K001; Exp. Date 06/30/2025 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: completed.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0455-2025%22
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