Northwind Pharmaceuticals Recalls Valsartan 320mg Due to Carcinogen Impurity
Northwind Pharmaceuticals is recalling 14 bottles of Valsartan 320mg tablets distributed in Indiana 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 pharmaceutical product represents a significant health risk, meeting the criteria for a Severe rating.
Plain-English summary
Northwind Pharmaceuticals LLC is recalling 14 bottles of Valsartan 320mg tablets (NDC: 51655-0654-52). The affected product is identified by Lot UT48100001 with an expiration date of 9/30/2019. 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.
The affected product was distributed in Indiana. Consumers and healthcare providers should check their inventory for this specific lot number and expiration date. If the product is found, it should be discontinued and returned to the pharmacy or point of purchase for a refund or replacement, as directed by the recalling firm.
The recalled product
- Product
- Valsartan, 320mg, 30 tablets per bottle, Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46256. NDC: 51655-0654-52
- Manufacturer
- Northwind Pharmaceuticals LLC
- Category
- Drug — Prescription Medication
- Affected units
- 14
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 (2)
- Lot: UT48100001
- exp 9/30/2019
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 4 recalled by Northwind Pharmaceuticals LLC 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 manufacturer · Northwind Pharmaceuticals LLC
See all →- ModerateDouble strength antibiotic bottles recalled over micro-organism on packaging coil
FDA (Drugs) · 2025-09-24
- HighPrescription drug recall for manufacturing quality control deviations
FDA (Drugs) · 2023-05-03
- HighTadalafil Tablets Recalled Due to Manufacturing Practice Violations
FDA (Drugs) · 2023-05-03
- ModerateTadalafil Tablets 20 mg recalled due to manufacturing deviations
FDA (Drugs) · 2023-05-03
- ModeratePrescription Drug Glimepiride Tablets Recalled Due to Manufacturing Deviations
FDA (Drugs) · 2023-05-03
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