Torrent Pharma Recalls Amlodipine and Valsartan Tablets Due to Impurity
Torrent Pharma Inc. is recalling Amlodipine and Valsartan Tablets because a carcinogen impurity was detected in the active pharmaceutical ingredient.
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 involves a carcinogen impurity, which constitutes a significant health risk and aligns with the 'Severe' criteria for significant injury or high-risk contamination.
Plain-English summary
Torrent Pharma Inc. is recalling Amlodipine and Valsartan Tablets, USP, 10 mg/160mg, 30 tablets per bottle. The recall involves 46,272 bottles distributed nationwide in the United States.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations, specifically the detection of a carcinogen impurity in the active pharmaceutical ingredient (API) used to manufacture the drug product. The affected batches are BV65D002, BV65C002, BV65C003, BV65C004, and BV65D001.
Consumers and healthcare providers should stop using the recalled medication and contact their healthcare provider for guidance on alternative treatment options. The product is prescription-only.
The recalled product
- Product
- Amlodipine and Valsartan Tablets, USP, 10 mg/160mg, 30 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-206-30
- Manufacturer
- Torrent Pharma Inc.
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 46,272
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: BV65D002
- BV65C002
- BV65C003
- BV65C004
- BV65D001
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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