The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1134-2018·Announced 2018-09-05

Torrent Pharma Recalls Valsartan Tablets Due to Carcinogen Impurity

Torrent Pharma Inc. is recalling specific batches of Valsartan Tablets USP, 80mg, 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 the detection of 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 24,468 bottles of Valsartan Tablets USP, 80mg, 90 tablets per bottle. The affected product is identified by NDC 13668-068-90 and includes specific batch numbers: BV46C007, BV46C008, BV46C009, BV46C010, BV46C011, BV46C012, BV46C003, and BV46C006. The product was 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. This is an FDA Class II recall, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

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 distributor or pharmacy for disposal or credit in accordance with standard recall procedures.

The recalled product

Product
Valsartan Tablets USP, 80mg, 90 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-068-90
Manufacturer
Torrent Pharma Inc.
Category
Drug — Prescription Medication
Hazard
Affected units
24,468

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 (8)

  • Batch: BV46C007
  • BV46C008
  • BV46C009
  • BV46C010
  • BV46C011
  • BV46C012
  • BV46C003
  • BV46C006

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 →

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