The Recall Desk
SevereFDA (Drugs)·D-1131-2018·Announced 2018-09-05

AvKARE Recalls Valsartan Tablets Due to Carcinogen Impurity

AvKARE is recalling specific lots of Valsartan 80 mg 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 medication constitutes a significant health risk, meeting the criteria for a Severe rating.

Plain-English summary

AvKARE, Inc. is recalling 728 cartons (36,400 tablets) of Valsartan Tablets, USP 80 mg. The affected product is identified by NDC 50268-784-15 and includes Lots 18492 (Exp. 11/2018) and 20169 (Exp. 05/2019). 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 units were distributed nationwide in the United States. The source text does not specify the exact number of patients affected or report any specific illnesses or injuries associated with the use of these tablets.

Consumers and healthcare providers should check their inventory for the specific NDC and lot numbers listed above. If the product is found, it should be discontinued and returned to the supplier or destroyed according to local regulations. Patients currently taking this medication should consult their healthcare provider for alternative treatment options.

The recalled product

Product
Valsartan Tablets, USP 80 mg Rx Only 50 Tablets (5x10) Unit Dose NDC 50268-784-15 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 (2)

  • Lots: 18492 Exp. 11/2018
  • 20169 Exp. 05/2019

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.

See all →

Same hazard · carcinogen impurity

See all →