The Recall Desk
SevereFDA (Drugs)·D-0321-2019·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

Illness, injury, or structural failure has been reported. 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, which corresponds to a Severe severity score under the rubric for significant injury or property damage reports or high-risk contamination.

Plain-English summary

Mylan Laboratories Limited is recalling Amlodipine and Valsartan Tablets, USP 10/160 mg, 30-count bottles. The recall involves 76,516 HDPE bottles distributed throughout the United States, including Puerto Rico. The affected lot numbers are 3064085, 3066063, 3069638, and 3069639.

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.

Consumers and healthcare providers should check their inventory for the specific lot numbers listed above. If the product is found, it should be returned to the pharmacy or distributor for a refund. Patients should consult their healthcare provider for alternative treatment options.

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
76,516

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 (4)

  • Lot numbers: 3064085
  • 3066063
  • 3069638
  • 3069639

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 · ndeA impurity

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