FDA Drug recall D-0124-2020
Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 tablets per bottle, Rx Only, Manufactured for: Torrent Pharma Inc., Bas…
- FDA Drug
- Class II
- ongoing
- Published 2019-10-09
On 2019-10-09 the FDA classified a Class II recall of Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 tablets per bottle, Rx Only, Manufactured for: Torrent Pharma Inc., Bas… by Torrent Pharma, citing CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level of 9.82 part….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0124-2020 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2019-09-19 |
| Published | 2019-10-09 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Torrent Pharma |
| Distribution | US |
Product
Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 tablets per bottle, Rx Only, Manufactured for: Torrent Pharma Inc., Basking Ridge, NJ 07920. NDC: 13668-118-90
Reason
CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level of 9.82 parts per million.
Identifiers
| code_info | Lot 4P04D007 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Other recalls by Torrent Pharma
- Fluoxetine Tablets, USP, 20 mg, 28-count Carton (4x7 Unit-dose), Manufactured by: TORRENT PHARMACEUTIALS LTD., Indrad-382 721 INDIA
FDA Drug · Class II · 2025-06-11 · Torrent Pharma - Fluoxetine Tablets, USP, 20 mg, 30-count bottle, Rx only, Manufactured by: TORRENT PHARMACEUTIALS LTD., Indrad-382 721 INDIA
FDA Drug · Class II · 2025-06-11 · Torrent Pharma - Pantoprazole Sodium Delayed-Release Tablets, USP, 20 mg, Rx Only, 90 tablets per bottle, Manufactured by: Torrent Pharmaceuticals Ltd., Ind…
FDA Drug · Class II · 2022-05-11 · Torrent Pharma - Carbamazepine Tablets, USP 200 mg 100 Tablets Rx only NDC 13668-268-01 Manufactured by: Torrent Pharmaceuticals Ltd
FDA Drug · Class II · 2022-01-19 · Torrent Pharma - Telmisartan and Hydrochlorothiazide Tablets, USP, 40 mg/12.5 mg, 30 count bottles, Rx only, Manufactured by: Torrent Pharmaceuticals LTD.,…
FDA Drug · Class III · 2021-12-22 · Torrent Pharma
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0124-2020%22
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