Torrent Pharma Recalls Valsartan Tablets Due to Carcinogen Impurity
Torrent Pharma Inc. is recalling specific batches of Valsartan Tablets USP, 160mg, 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 meets the rubric criteria for a Severe rating due to the potential for significant health consequences.
Plain-English summary
Torrent Pharma Inc. is recalling 14,016 bottles of Valsartan Tablets USP, 160mg, 90 tablets per bottle. The affected product is identified by NDC 13668-069-90 and includes batches BV47C005, BV47C006, BV47D001, BV47C003, and BV47C004. The product was 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.
Consumers and healthcare providers should check their inventory for the specific NDC and batch numbers listed above. If the product matches the recalled description, it should be discontinued and returned to the pharmacy or supplier for disposal or credit.
The recalled product
- Product
- Valsartan Tablets USP, 160mg, 90 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-069-90
- Manufacturer
- Torrent Pharma Inc.
- Category
- Drug — Prescription Medication
- Affected units
- 14,016
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: BV47C005
- BV47C006
- BV47D001
- BV47C003
- BV47C004
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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