The Recall Desk
SevereFDA (Drugs)·D-1132-2018·Announced 2018-09-05

AvKARE Recalls Valsartan Tablets Due to Carcinogen Impurity in API

AvKARE, Inc. is recalling specific lots of Valsartan Tablets 160 mg because a carcinogen impurity was detected in the active pharmaceutical ingredient used to manufacture the drug.

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 hazard involves a carcinogen impurity, which aligns with the rubric criteria for Severe severity (FDA Class II with significant health risk).

Plain-English summary

AvKARE, Inc. is voluntarily recalling 818 cartons (40,900 tablets) of Valsartan Tablets, USP 160 mg, NDC 50268-785-15. The affected lots are 17717 (Exp. 07/2018), 18493 (Exp. 01/2019), and 19761 (Exp. 04/2019). 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 nationwide in the United States. The source text does not specify the exact number of patients affected or report any illnesses or injuries associated with the use of these tablets.

Consumers and healthcare providers should stop using the affected lots of Valsartan Tablets and contact their healthcare provider for alternative treatment options. Patients should not discontinue their medication without consulting their doctor, as stopping blood pressure medication abruptly can be dangerous.

The recalled product

Product
Valsartan Tablets, USP 160 mg Rx Only 50 Tablets (5x10) Unit Dose NDC 50268-785-15 Manufactured for: AvKARE, Inc. Pulaski, TN 38478
Manufacturer
AVKARE Inc.
Category
Drug — Antihypertensive
Hazard

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 (3)

  • Lots: 17717 Exp. 07/2018
  • 18493 Exp. 01/2019
  • 19761 Exp. 04/2019

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 4 recalled by AVKARE Inc. 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 · AVKARE Inc.

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Same hazard · carcinogen impurity

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