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.
What this means for you
Illness, injury, or structural failure has been reported. 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
- 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 →Related recalls
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- SevereAurobindo Recalls Valsartan Tablets Due to NDEA Impurity
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- SevereAurobindo Pharma Recalls Valsartan Tablets Due to NDEA Impurity
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Same manufacturer · Hetero Labs Limited Unit V
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- CriticalHetero Labs Recalls Montelukast Sodium Tablets Due to Labeling Error
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- SevereHetero Labs Recalls Valsartan Tablets Due to Carcinogen Impurity
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Same hazard · carcinogen impurity
See all →- SevereMacleods Pharma Recalls Losartan Potassium and Hydrochlorothiazide Tablets Due to Carcinogen
FDA (Drugs) · 2019-03-27
- SevereAurobindo Recalls Irbesartan Bulk Ingredient Due to Carcinogen Impurity
FDA (Drugs) · 2018-11-07
- SevereAvKARE Valsartan and Hydrochlorothiazide Tablets Recalled for Carcinogen Impurity
FDA (Drugs) · 2018-09-12
- SevereAvKARE Valsartan and Hydrochlorothiazide Tablets Recalled for Carcinogen Impurity
FDA (Drugs) · 2018-09-12
- SevereAvKARE Valsartan and Hydrochlorothiazide Tablets Recalled for Carcinogen Impurity
FDA (Drugs) · 2018-09-12