Agency classClass IIOur severity:Severe FDA (Drugs)·D-0305-2019·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 5 mg/320 mg because FDA testing confirmed the presence of 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 classification is FDA Class II, and the presence of NDEA, a potential carcinogen, in a prescription drug constitutes a significant health risk warranting a Severe rating.

Plain-English summary

Teva Pharmaceuticals USA is recalling 75,883 bottles of Amlodipine and Valsartan Tablets 5 mg/320 mg. The affected products are available in 30-count bottles (NDC 0093-7692-56) and 90-count bottles (NDC 0093-7692-98). The specific lots involved are 25X028, 25X029, 25X030, 25X031, 25X032, 25X035, and 25X037. These prescription-only medications were manufactured in Israel by TEVA PHARMACEUTICAL IND. LTD. for TEVA PHARMACEUTICALS USA, INC.

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. FDA laboratory testing confirmed the presence of an impurity, N-nitrosodimethylamine (NDEA), in the product. NDEA is a potential carcinogen that can form during the manufacturing process of certain pharmaceuticals.

The affected products were distributed nationwide in the United States, including Puerto Rico. Patients and healthcare providers should check their medication bottles for the specific NDC numbers and lot numbers listed above. If the medication matches the recalled lots, patients should stop taking it and contact their healthcare provider for guidance on alternative treatment options.

The recalled product

Product: Amlodipine and Valsartan Tablets 5 mg/320 mg, (a) 30-count bottles (NDC 0093-7692-56) & 90-count bottles (NDC 0093-7692-98), 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: ndeA-impurity
carcinogen-risk
Affected units: 75,883

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 (7)

NDC 0093-7692-56 & NDC 0093-7692-98 Lot # 25X028
25X029
25X030
25X031
25X032
25X035
25X037

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 · ndeA impurity