Fluoxetine Tablets — Class II drug recall D-0455-2025
Completed recall by Torrent Pharma Inc., reported 2025-06-11, distributed nationwide. CGMP Deviations: Presence of N-Nitroso Fluoxetine exceeding interim acceptable intake limit.
| Recall number | D-0455-2025 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Completed |
| Voluntary or mandated | Voluntary |
| Recalling firm | Torrent Pharma Inc., Basking Ridge, NJ, United States |
| Recall initiated | 2025-05-27 |
| Classified | 2025-06-02 |
| Reported by FDA | 2025-06-11 |
| Distributed | Nationwide (US) |
| Quantity | 3,672 bottles |
| Reason classes | cgmp |
| NDC | 13668-0443, 13668-0443-01, 13668-0443-10, 13668-0443-30, 13668-0443-74, 13668-0443-91, 13668-0473, 13668-0473-01, 13668-0473-10, 13668-0473-30, 13668-0473-74, 13668-0473-91 |
| Lot numbers | BDX6K001 |
| Expiration dates | 2025-06-30 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0455-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.