Torrent Pharma Recalls Losartan Potassium Tablets Due to Impurity
Torrent Pharma Inc. is recalling Losartan Potassium Tablets 50mg because FDA testing found an impurity above acceptable levels.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, and the rubric specifies that FDA Class II recalls with significant health risks or reports of hospitalization are rated as Severe (4).
Plain-English summary
Torrent Pharma Inc. is recalling Losartan Potassium Tablets, USP 50mg (NDC: 13668-409-10). The recall involves 8,688 bottles of 1,000 tablets each, identified by Lot 4DU2E009. These prescription-only medications were distributed nationwide in the United States and Puerto Rico.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. FDA laboratory testing confirmed the presence of the impurity N-Methylnitrosobutyric acid (NMBA) in the finished product. The detected levels of this impurity exceeded the interim acceptable daily intake limit of 9.82 parts per million.
Consumers and healthcare providers should stop using the affected tablets and contact their healthcare provider for guidance on alternative treatment options. The recalling firm is Torrent Pharma Inc., located in Basking Ridge, New Jersey.
The recalled product
- Product
- Losartan Potassium Tablets, USP 50mg, 1000 tablets per bottle, Rx Only, Manufactured for: Torrent Pharma Inc., Basking Ridge, NJ 07920. NDC: 13668-409-10
- Manufacturer
- Torrent Pharma Inc.
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 8,688
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot 4DU2E009
Distribution
Part of a larger recall action
This product is one of 4 recalled by Torrent Pharma Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 4 products in this recall →Related recalls
Same manufacturer · Torrent Pharma Inc.
See all →- SevereFluoxetine Tablets 20 mg Recalled for N-Nitroso Impurity
FDA (Drugs) · 2025-06-11
- HighFluoxetine Tablets USP 20 mg Recalled for N-Nitroso Contamination
FDA (Drugs) · 2025-06-11
- High
- ModerateCarbamazepine tablets recalled for failed dissolution specifications
FDA (Drugs) · 2022-01-19
- ModerateTelmisartan and Hydrochlorothiazide Tablets Recalled for Superpotency
FDA (Drugs) · 2021-12-22
Same hazard · impurity
See all →- ModerateHikma Recalls Ramipril Capsules Due to Process Impurity
FDA (Drugs) · 2026-09-02
- ModerateMedline Remedy Specialized Silicone Cream Recalled for Elevated Formaldehyde Levels
FDA (Drugs) · 2026-07-15
- SevereCinacalcet Hydrochloride Tablets Recalled for Elevated Impurity Levels
FDA (Drugs) · 2026-07-08
- HighDuloxetine 30mg delayed-release capsules exceed nitrosamine impurity interim limit
FDA (Drugs) · 2026-06-17
- HighDuloxetine 60mg delayed-release capsules exceed nitrosamine impurity interim limit
FDA (Drugs) · 2026-06-17