The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1175-2018·Announced 2018-09-12

AvKARE Valsartan and Hydrochlorothiazide Tablets Recalled for Carcinogen Impurity

AvKARE is recalling specific lots of Valsartan and Hydrochlorothiazide tablets because a carcinogen impurity was detected in the active pharmaceutical ingredient.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. 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 criteria for Severe severity (FDA Class II with significant health risk).

Plain-English summary

AvKARE Incorporated is recalling 19,109 bottles of AvKARE Valsartan and Hydrochlorothiazide 160 mg/25 mg tablets. 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 is distributed nationwide. The specific lots subject to recall are 17325, 17856, 18396, 18702, 19020, 19222, 20030, and 20381, with expiration dates ranging from September 2018 to April 2019. The product is identified by NDC 42291-887-90.

Consumers and healthcare providers should check their inventory for these specific lot numbers and expiration dates. If the product matches the recalled lots, it should be discontinued and returned to the pharmacy or supplier for disposal or credit. Patients should consult their healthcare provider for alternative treatment options if they have been taking the affected medication.

The recalled product

Product
AvKARE Valsartan and Hydrochlorothiazide 160 mg/25 mg tablets, 90-count bottle, Rx Only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478, NDC 42291-887-90
Manufacturer
Avkare Incorporated
Category
Drug — Antihypertensive
Hazard
Affected units
19,109

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 (8)

  • Lots: 17325 Exp. 09/2018
  • 17856 Exp. 09/2018
  • 18396 Exp. 09/2018
  • 18702 Exp. 02/2019
  • 19020 Exp. 02/2019
  • 19222 Exp. 02/2019
  • 20030 Exp. 04/2019
  • 20381 Exp. 04/2019

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 5 recalled by Avkare Incorporated 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 5 products in this recall →

Related recalls

Same manufacturer · Avkare Incorporated

See all →

Same hazard · carcinogen impurity

See all →

Similar recalls