The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1114-2018·Announced 2018-08-29

Hetero Labs Recalls Valsartan Tablets Due to Carcinogen Impurity

Hetero Labs Limited is recalling 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 detection of a carcinogen impurity in a prescription drug represents a significant health risk, aligning with the 'Severe' criteria for significant injury or risk reports.

Plain-English summary

Hetero Labs Limited Unit V is recalling Valsartan Tablets, USP, 80 mg, 90 count bottles. The product is manufactured for Camber Pharmaceuticals, Inc. and distributed nationwide. The recall involves 394,896 bottles with expiration dates ranging from July 2018 to June 2020.

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.

Consumers should stop using the affected Valsartan tablets and contact their healthcare provider for alternative treatment options. The affected product is identified by NDC 31722-746-90 and UPC 331722746908.

The recalled product

Product
VALSARTAN (VALSARTAN)
Brand
VALSARTAN
Manufacturer
Hetero Labs Limited Unit V
Category
Drug — Prescription Drug
Hazard
Affected units
394,896

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 (1)

  • All Lots with expiration dates 7/2018 to 6/2020

UPCs (1)

  • 331722746908

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 4 recalled by Hetero Labs Limited Unit V 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 4 products in this recall →

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