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.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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.
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