The Recall Desk
SevereFDA (Drugs)·D-1133-2018·Announced 2018-09-05

AvKARE Recalls Valsartan Tablets Due to Carcinogen Impurity

AvKARE Inc. is recalling Valsartan Tablets 320 mg 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 involves a carcinogen impurity, which aligns with the rubric criterion for 'Severe' (FDA Class II with significant health risk).

Plain-English summary

AvKARE Inc. is recalling Valsartan Tablets, USP 320 mg, NDC 50268-786-13. The recall involves 1,496 cartons containing a total of 44,880 tablets. The affected lots are 17718 (Exp. 07/2018), 18700 (Exp. 01/2019), 19133 (Exp. 02/2019), and 19532 (Exp. 04/2019). The product was distributed nationwide in the United States.

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 and healthcare providers should stop using the affected Valsartan Tablets and contact their healthcare provider for alternative treatment options. The source text does not specify a particular action for disposal or return, but standard recall procedures generally involve contacting the manufacturer or a healthcare provider for guidance.

The recalled product

Product
Valsartan Tablets, USP 320 mg Rx Only 30 Tablets (6x5) Unit Dose NDC 50268-786-13 Manufactured for: AvKARE, Inc. Pulaski, TN 38478
Manufacturer
AVKARE Inc.
Category
Drug — Prescription Medication
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 (4)

  • Lots: 17718 Exp. 07/2018
  • 18700 Exp. 01/2019
  • 19133 Exp. 02/2019
  • 19532 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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