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 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
- 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 →Related recalls
Same brand · VALSARTAN
- ModerateCardinal Health Recalls Valsartan Tablets Due to Temperature Excursions
FDA (Drugs) · 2021-06-02
- SevereAurobindo Pharma Recalls Valsartan Tablets Due to NDEA Impurity
FDA (Drugs) · 2019-03-27
- SevereAurobindo Recalls Valsartan Tablets Due to NDEA Impurity
FDA (Drugs) · 2019-03-27
- SevereAurobindo Recalls Valsartan Tablets Due to NDEA Impurity
FDA (Drugs) · 2019-03-27
- SevereAurobindo Pharma Recalls Valsartan Tablets Due to NDEA Impurity
FDA (Drugs) · 2019-03-27
Same manufacturer · Hetero Labs Limited Unit V
See all →- ModeratePantoprazole Sodium Tablets Recalled for Discoloration Issues
FDA (Drugs) · 2026-04-29
- ModerateHetero Labs Recalls Losartan Potassium Tablets Due to Bulging Complaints
FDA (Drugs) · 2020-09-02
- 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