The Recall Desk
SevereFDA (Drugs)·D-0324-2019·Announced 2018-12-19

Mylan Recalls Valsartan Tablets Due to NDEA Impurity

Mylan is recalling specific lots of Valsartan 40 mg tablets because FDA analysis found trace amounts of the impurity N-nitrosodiethylamine (NDEA).

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, particularly given the presence of a known carcinogenic impurity (NDEA) in a prescription drug.

Plain-English summary

Mylan Laboratories Limited is recalling 160,300 bottles of Valsartan Tablets, USP 40 mg, 30-count bottles. The affected product is a prescription-only medication manufactured in India for Mylan Pharmaceuticals, Inc. The recall covers specific lot numbers: 3063780, 3074879, 3086684, and 3086687.

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. This finding represents a Good Manufacturing Practice (GCMP) deviation.

The product was distributed throughout the United States to several major distributors, including Puerto Rico. Patients and healthcare providers should check their medication bottles for the listed lot numbers and NDC codes (0378-5807-93, 0378-5813-77, 0378-5814-77, 0378-5815-77). If the medication matches the recalled lots, patients should stop taking it and contact their healthcare provider for a replacement or alternative treatment.

The recalled product

Product
VALSARTAN (VALSARTAN)
Brand
VALSARTAN
Manufacturer
Mylan Laboratories Limited, (Nashik FDF)
Category
Drug — Prescription Drug
Hazard
Affected units
160,300

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: 3063780
  • 3074879
  • 3086684
  • 3086687

UPCs (4)

  • 0303785815778
  • 0303785813774
  • 0303785807933
  • 0303785814771

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 · VALSARTAN

Same manufacturer · Mylan Laboratories Limited, (Nashik FDF)

See all →

Same hazard · impurity

See all →