The Recall Desk
SevereFDA (Drugs)·D-0322-2019·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 N-nitrosodiethylamine (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. According to the rubric, FDA Class II recalls with potential for adverse health consequences (such as nitrosamine impurities) are categorized as Severe (Score 4), especially when no specific hospitalization reports are cited to elevate it to Critical, but the hazard is significant.

Plain-English summary

Mylan Laboratories Limited is recalling Amlodipine and Valsartan Tablets, USP 5/320 mg, 30-count bottles. The product is a prescription medication manufactured in India for Mylan Pharmaceuticals, Inc. The recall involves 109,314 HDPE bottles distributed throughout the United States, including Puerto Rico.

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. The agency classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

Consumers and healthcare providers should check their inventory for the specific lot numbers listed in the recall notice. If the product is found, it should be returned to the pharmacy or distributor for replacement or refund. Patients should consult their healthcare provider for alternative treatment options if they are currently taking this medication.

The recalled product

Product
AMLODIPINE AND VALSARTAN (AMLODIPINE AND VALSARTAN)
Brand
AMLODIPINE AND VALSARTAN
Manufacturer
Mylan Laboratories Limited, (Nashik FDF)
Category
Drug — Prescription Medication
Hazard
Affected units
109,314

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 (9)

  • Lot Numbers: 3064086
  • 3066061
  • 3066062
  • 3073145
  • 3073146
  • 3073147
  • 3076091
  • 3077619
  • 3082432

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 · nitrosamine impurity

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