Torrent Pharma Recalls Amlodipine and Valsartan Tablets Due to Carcinogen Impurity
Torrent Pharma Inc. is recalling specific batches of 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 the presence of a carcinogen impurity in a prescription drug represents a significant health risk, meeting the criteria for a Severe rating.
Plain-English summary
Torrent Pharma Inc. is recalling 78,144 bottles of Amlodipine and Valsartan Tablets, USP, 5 mg/160 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 the detection of a carcinogen impurity in the active pharmaceutical ingredient (API) used to manufacture the drug product. The affected batches are identified by the following codes: BV53D004, BV53C006, BV53D001, BV53D002, BV53D003, BV53C004, and BV53C005.
Consumers who have this medication should check their bottles for the NDC 13668-207-30 and the batch codes listed above. If the product matches the recalled description, they should stop using it and contact their healthcare provider or pharmacist for guidance on alternative treatment options.
The recalled product
- Product
- Amlodipine and Valsartan Tablets, USP, 5 mg/160 mg, 30 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-207-30
- Manufacturer
- Torrent Pharma Inc.
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 78,144
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 (7)
- Batch: BV53D004
- BV53C006
- BV53D001
- BV53D002
- BV53D003
- BV53C004
- BV53C005
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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