Torrent Pharma Recalls Valsartan Tablets Due to Carcinogen Impurity
Torrent Pharma Inc. is recalling specific batches of Valsartan Tablets USP, 320mg, because a carcinogen impurity was detected in the active pharmaceutical ingredient.
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 involves a carcinogen impurity, which aligns with the rubric criteria for Severe severity (FDA Class II with significant health risks).
Plain-English summary
Torrent Pharma Inc. is recalling Valsartan Tablets USP, 320mg, 90 tablets per bottle (NDC: 13668-070-90). The recall affects batches BV48D001 and BV48D001, which were distributed nationwide in the United States.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, a carcinogen impurity was detected in the active pharmaceutical ingredient (API) used to manufacture the drug product.
Consumers and healthcare providers should stop using the affected batches and contact their healthcare provider for alternative treatment options. The recalling firm is Torrent Pharma Inc.
The recalled product
- Product
- Valsartan Tablets USP, 320mg, 90 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-070-90
- Manufacturer
- Torrent Pharma Inc.
- Category
- Drug — Antihypertensive
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 (2)
- Batch: BV48D001
- BV48D002
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 12 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 12 products in this recall →Related recalls
Same manufacturer · Torrent Pharma Inc.
See all →- HighFluoxetine Tablets USP 20 mg Recalled for N-Nitroso Contamination
FDA (Drugs) · 2025-06-11
- SevereFluoxetine Tablets 20 mg Recalled for N-Nitroso Impurity
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 · carcinogen impurity
See all →- SevereMacleods Pharma Recalls Losartan Potassium and Hydrochlorothiazide Tablets Due to Carcinogen
FDA (Drugs) · 2019-03-27
- SevereAurobindo Recalls Irbesartan Bulk Ingredient Due to Carcinogen Impurity
FDA (Drugs) · 2018-11-07
- SevereAvKARE Valsartan and Hydrochlorothiazide Tablets Recalled for Carcinogen Impurity
FDA (Drugs) · 2018-09-12
- SevereAvKARE Valsartan and Hydrochlorothiazide Tablets Recalled for Carcinogen Impurity
FDA (Drugs) · 2018-09-12
- SevereAvKARE Valsartan and Hydrochlorothiazide Tablets Recalled for Carcinogen Impurity
FDA (Drugs) · 2018-09-12