Agency classClass IIOur severity:Severe FDA (Drugs)·D-0304-2019·Announced 2018-12-19

Teva Recalls Amlodipine and Valsartan Tablets Due to NDEA Impurity

Teva Pharmaceuticals USA is recalling specific lots of Amlodipine and Valsartan Tablets because FDA testing found the impurity N-nitrosodimethylamine (NDEA).

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 agency classified this as an FDA Class II recall. Per the rubric, FDA Class II recalls involving significant health risks like nitrosamine impurities are categorized as Severe (Score 4), as they do not meet the Class I criteria for Critical but represent a serious potential health hazard.

Plain-English summary

Teva Pharmaceuticals USA is recalling 39,617 bottles of Amlodipine and Valsartan Tablets 10 mg/160 mg. The affected products are 30-count bottles (NDC 0093-7961-56) and 90-count bottles (NDC 0093-7691-98) manufactured in Israel by Teva Pharmaceutical Ind. Ltd. and distributed nationwide in the USA, including Puerto Rico.

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. FDA laboratory testing confirmed the presence of the impurity N-nitrosodimethylamine (NDEA) in the product. The specific lots affected are # 24X012 and # 24X013.

Consumers with these specific NDCs and lot numbers should stop using the medication and contact their healthcare provider or pharmacist for guidance on alternative treatment options.

The recalled product

Product: Amlodipine and Valsartan Tablets 10 mg/160 mg, (a) 30-count bottles (NDC 0093-7961-56) & 90-count bottles (NDC 0093-7691-98), RX Only, Manufactured In Israel By: TEVA PHARMACEUTICAL IND. LTD. Jerusalem, 9777402, Israel, Manufactured For: TEVA PHARMACEUTICALS USA, INC. North…
Manufacturer: Teva Pharmaceuticals USA
Category: Drug — Prescription Medication
Hazard: nitrosamine-impurity
Affected units: 39,617

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)

NDC 0093-7691-56 & NDC 0093-7691-98 Lot # 24X012
24X013

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 8 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 8 products in this recall →

Same manufacturer · Teva Pharmaceuticals USA

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Same hazard · nitrosamine impurity