Torrent Pharma Recalls Amlodipine, Valsartan, and Hydrochlorothiazide Tablets
Torrent Pharma Inc. is recalling specific batches of Amlodipine, Valsartan, and Hydrochlorothiazide tablets due to the detection of a carcinogen impurity 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 the detection of a carcinogen impurity in a pharmaceutical product constitutes a significant health hazard, meeting the criteria for a Severe rating.
Plain-English summary
Torrent Pharma Inc. is recalling 34,320 bottles of Amlodipine, Valsartan, and Hydrochlorothiazide Tablets, USP, 10 mg/160 mg/25 mg. The affected product is a prescription medication manufactured by Torrent Pharmaceuticals LTD. in India and distributed nationwide in the United States.
The recall was initiated because a carcinogen impurity was detected in the active pharmaceutical ingredient (API) used to manufacture the drug product. This finding represents a deviation from Current Good Manufacturing Practices (CGMP). The specific batches affected are BBX9D004, BBX9E001, BBX9D001, BBX9D002, and BBX9D003.
Consumers and healthcare providers should check their inventory for these specific NDCs and batch numbers. If the product is found, it should be discontinued and returned to the pharmacy or distributor for proper disposal or credit. Patients should consult their healthcare provider for alternative treatment options.
The recalled product
- Product
- Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP, 10 mg/160 mg/25 mg, 30 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-328-30
- Manufacturer
- Torrent Pharma Inc.
- Category
- Drug — Prescription Medication
- Affected units
- 34,320
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 (5)
- Batch: BBX9D004
- BBX9E001
- BBX9D001
- BBX9D002
- BBX9D003
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