The Recall Desk
HighFDA (Drugs)·D-0323-2019·Announced 2018-12-19

Mylan Recalls Amlodipine and Valsartan Tablets Due to NDEA Impurity

Mylan is recalling Amlodipine and Valsartan tablets because FDA analysis found trace amounts of the impurity NDEA in the active ingredient.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a high-risk impurity (NDEA) without reported illnesses or injuries, which aligns with the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Mylan Laboratories Limited is recalling Amlodipine and Valsartan Tablets, USP 10/320 mg, 30-count bottles. The recall involves 84,066 HDPE bottles distributed throughout the United States, including Puerto Rico, to several major distributors.

The recall was initiated because FDA analysis confirmed the presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA), in the active pharmaceutical ingredient (API) used to manufacture the product. NDEA is a potential carcinogen.

Patients and consumers should stop using the affected products and contact their healthcare provider for a replacement. The affected lot numbers are 3066064, 3069645, 3069646, 3073142, 3073143, 3073144, and 3077617.

The recalled product

Product
AMLODIPINE AND VALSARTAN (AMLODIPINE AND VALSARTAN)
Brand
AMLODIPINE AND VALSARTAN
Manufacturer
Mylan Laboratories Limited, (Nashik FDF)
Category
Drug — Prescription Drug
Hazard
Affected units
84,066

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)

  • Lot Numbers: 3066064
  • 3069645
  • 3069646
  • 3073142
  • 3073143
  • 3073144
  • 3077617

UPCs (4)

  • 0303781722933
  • 0303781723930
  • 0303781721936
  • 0303781724937

Distribution

Distributed in 1 state:

Part of a larger recall action

This product is one of 13 recalled by Mylan Laboratories Limited, (Nashik FDF) 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 13 products in this recall →

Related recalls

Same brand · AMLODIPINE AND VALSARTAN

Same manufacturer · Mylan Laboratories Limited, (Nashik FDF)

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Same hazard · nde impurity

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