Torrent Pharma Recalls Amlodipine, Valsartan, and Hydrochlorothiazide Tablets Due to Impurity
Torrent Pharma Inc. is recalling specific batches of Amlodipine, Valsartan, and Hydrochlorothiazide tablets 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 169,200 bottles of Amlodipine, Valsartan, and Hydrochlorothiazide Tablets, USP, 10 mg/320 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 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. The recall covers 30 specific batch codes, including BBX2D025, BBX2D026, and BBX2E001, among others.
Patients and healthcare providers should check their medication bottles for the NDC 13668-325-30 and the specific batch codes listed in the recall notice. If the medication matches the recalled batches, it should be returned to the pharmacy for replacement or refund. Patients should consult their healthcare provider for alternative treatment options if necessary.
The recalled product
- Product
- Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP, 10 mg/320 mg/25 mg, 30 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-325-30
- Manufacturer
- Torrent Pharma Inc.
- Category
- Drug — Prescription Medication
- Affected units
- 169,200
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 (20)
- Batch: BBX2D025
- BBX2D026
- BBX2E001
- BBX2E002
- BBX2E003
- BBX2E004
- BBX2E005
- BBX2D003
- BBX2D004
- BBX2D005
- BBX2D006
- BBX2D007
- BBX2D008
- BBX2D015
- BBX2D016
- BBX2D017
- BBX2D018
- BBX2D019
- BBX2D020
- BBX2D021
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.
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