The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1113-2018·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 presence of a carcinogen impurity in a prescription drug represents a significant health risk, aligning with the 'Severe' criteria for significant injury or health hazard reports.

Plain-English summary

Hetero Labs Limited Unit V is recalling Valsartan Tablets, USP, 40 mg, manufactured for Camber Pharmaceuticals, Inc. The recall involves 316,380 bottles of the medication, which were distributed nationwide. The affected products include all lots 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 who have this medication should stop using it and contact their healthcare provider for guidance on alternative treatments. Patients should not discontinue their medication without consulting a medical professional.

The recalled product

Product
VALSARTAN (VALSARTAN)
Brand
VALSARTAN
Manufacturer
Hetero Labs Limited Unit V
Category
Drug — Prescription Medication
Hazard
Affected units
316,380

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)

  • 331722745307

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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