Home / Recalls / Torrent Pharma Inc. / D-0456-2025

D-0456-2025 Class II Ongoing

Recalled by Torrent Pharma Inc. — Basking Ridge, NJ

Recall Details

Product Type
Drugs
Report Date
June 11, 2025
Initiation Date
May 27, 2025
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
972 Cartons

Product Description

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)

Reason for Recall

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

Distribution Pattern

U.S. Nationwide.

Code Information

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

Other recalls by Torrent Pharma Inc.

  • D-0455-2025 Class II — Fluoxetine Tablets, USP, 20 mg, 30-count bottle, Rx only, Manufactured by: TORR (May 27, 2025)
  • D-0852-2022 Class II — Pantoprazole Sodium Delayed-Release Tablets, USP, 20 mg, Rx Only, 90 tablets per (April 11, 2022)
  • D-0365-2022 Class II — Carbamazepine Tablets, USP 200 mg 100 Tablets Rx only NDC 13668-268-01 Manufactu (December 2, 2021)
  • D-0285-2022 Class III — Telmisartan and Hydrochlorothiazide Tablets, USP, 40 mg/12.5 mg, 30 count bottle (December 1, 2021)
  • D-0166-2021 Class I — Anagrelide Capsules, USP 1 mg, 100 capsules, Rx only, Manufactured in India for: (November 25, 2020)
  • D-1317-2020 Class II — Carbamazepine Tablets, USP 200 mg, packaged in a 500-count bottle, Rx only, Manu (May 11, 2020)
  • D-0123-2020 Class II — Losartan Potassium /Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 90 tablets per (September 19, 2019)
  • D-0124-2020 Class II — Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 tablets per (September 19, 2019)
  • D-0122-2020 Class II — Losartan Potassium Tablets, USP 100 mg, [90 or 1000] tablets per bottle, Rx Only (September 19, 2019)
  • D-0121-2020 Class II — Losartan Potassium Tablets, USP 50mg, 1000 tablets per bottle, Rx Only, Manufact (September 19, 2019)