Agency classClass IIOur severity:Severe FDA (Drugs)·D-0989-2018·Announced 2018-08-01

Teva Recalls Valsartan Tablets Due to Carcinogen Impurity in API

Teva Pharmaceuticals USA is recalling specific lots of Valsartan Tablets 320 mg 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 the hazard involves a carcinogen impurity, which aligns with the rubric criteria for Severe severity (FDA Class II with significant health risks).

Plain-English summary

Teva Pharmaceuticals USA is recalling Valsartan Tablets, USP 320 mg, in 90-count and 500-count bottles. The recall involves specific lot numbers for NDC 0591-2170-19 and NDC 0591-2170-05. The product was distributed throughout the United States, including Hawaii and Puerto Rico.

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 lots and contact their healthcare provider for alternative treatment options. The affected lots are identified by the specific NDC and lot numbers listed in the recall notice.

The recalled product

Product: Valsartan Tablets, USP 320 mg, 90-count bottle (NDC 0591-2170-19), 500-count bottle (NDC 0591-2170-05), Rx Only, Rx Only, Manufactured by: Arrow Pharma (Malta) Ltd. India, Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054.
Manufacturer: Teva Pharmaceuticals USA
Category: Drug — Antihypertensive
Hazard: carcinogen-impurity
cgmp-deviation

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 (5)

NDC 0591-2170-19 Lot Numbers: 1208002A
1247282M
1263944M NDC 0591-2170-05 Lot Numbers: 1208000M
1208001M
1240425A

Distribution

Distributed in 2 states:

Part of a larger recall action

This product is one of 9 recalled by Teva Pharmaceuticals USA 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 9 products in this recall →

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Same hazard · carcinogen impurity