FDA Drug recall D-0122-2020
Losartan Potassium Tablets, USP 100 mg, [90 or 1000] tablets per bottle, Rx Only, Manufactured for: Torrent Pharma Inc., Basking Ridge, NJ…
- FDA Drug
- Class II
- ongoing
- Published 2019-10-09
On 2019-10-09 the FDA classified a Class II recall of Losartan Potassium Tablets, USP 100 mg, [90 or 1000] tablets per bottle, Rx Only, Manufactured for: Torrent Pharma Inc., Basking Ridge, NJ… 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-0122-2020 |
| 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 Tablets, USP 100 mg, [90 or 1000] tablets per bottle, Rx Only, Manufactured for: Torrent Pharma Inc., Basking Ridge, NJ 07920. NDC 90 tablets: 13668-115-90; NDC 1000 tablets: 13668-115-10
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 | Count, lot, expiry: [90 count] Lot 4DU3E009, exp 12/31/2020; [1000 count] Lot 4DU3D018, exp 02/28/2021 |
|---|
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-0122-2020%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.