Hetero Labs Recalls Valsartan Tablets Due to Carcinogen Impurity
Hetero Labs 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 presence of a carcinogen impurity in a prescription drug represents a significant health risk, meeting the criteria for a Severe rating.
Plain-English summary
Hetero Labs Limited Unit V is recalling Valsartan Tablets, USP, 320 mg, manufactured for Camber Pharmaceuticals, Inc. The recall involves 441,408 bottles distributed nationwide. The affected lots have expiration dates ranging from July 2018 to June 2020.
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. This impurity poses a potential health risk to patients taking the medication.
Patients and consumers should stop using the affected Valsartan tablets and contact their healthcare provider for guidance on alternative treatments. The product is available under prescription only.
The recalled product
- Product
- VALSARTAN (VALSARTAN)
- Brand
- VALSARTAN
- Manufacturer
- Hetero Labs Limited Unit V
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 441,408
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)
- 331722748902
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
Same brand · VALSARTAN
- ModerateCardinal Health Recalls Valsartan Tablets Due to Temperature Excursions
FDA (Drugs) · 2021-06-02
- SevereAurobindo Recalls Valsartan Tablets Due to NDEA Impurity
FDA (Drugs) · 2019-03-27
- SevereAurobindo Pharma Recalls Valsartan Tablets Due to NDEA Impurity
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- SevereAurobindo Recalls Valsartan Tablets Due to NDEA Impurity
FDA (Drugs) · 2019-03-27
- SevereAurobindo Pharma Recalls Valsartan Tablets Due to NDEA Impurity
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Same manufacturer · Hetero Labs Limited Unit V
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FDA (Drugs) · 2026-04-29
- ModerateHetero Labs Recalls Losartan Potassium Tablets Due to Bulging Complaints
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- ModerateHetero Recalls Montelukast Sodium Tablets Due to Blue Specks
FDA (Drugs) · 2018-10-03
- CriticalHetero Labs Recalls Montelukast Sodium Tablets Due to Labeling Error
FDA (Drugs) · 2018-10-03
- SevereHetero Labs Recalls Valsartan Tablets Due to Carcinogen Impurity
FDA (Drugs) · 2018-08-29
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