The Recall Desk
SevereFDA (Drugs)·D-0330-2019·Announced 2018-12-19

Mylan Recalls Valsartan and Hydrochlorothiazide Tablets Due to NDEA Impurity

Mylan Laboratories is recalling Valsartan and Hydrochlorothiazide tablets because FDA analysis found trace amounts of the impurity N-nitrosodiethylamine (NDEA) in the active pharmaceutical 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 source text identifies this as an FDA Class II recall involving a nitrosamine impurity (NDEA), which falls under the 'Severe' category per the rubric for significant potential health risks.

Plain-English summary

Mylan Laboratories Limited is recalling Valsartan and Hydrochlorothiazide Tablets, USP 160/25 mg, in 90-count and 500-count bottles. The recall involves 22,813 HDPE bottles distributed throughout the United States, including Puerto Rico, to several major distributors. The affected lot numbers are 3084887, 3093802, and 3084888.

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 is classified as an FDA Class II recall.

Consumers with this medication should stop using it and contact their healthcare provider or pharmacist for guidance on alternative treatment options. The product is a prescription-only medication manufactured in India for Mylan Pharmaceuticals, Inc.

The recalled product

Product
VALSARTAN AND HYDROCHLOROTHIAZIDE (VALSARTAN AND HYDROCHLOROTHIAZIDE)
Brand
VALSARTAN AND HYDROCHLOROTHIAZIDE
Manufacturer
Mylan Laboratories Limited, (Nashik FDF)
Category
Drug — Prescription Medication
Hazard
Affected units
22,813

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 (1)

  • Lot numbers: 3084887 3093802 3084887 3084888 3093802

UPCs (1)

  • 0303786323777

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 AND HYDROCHLOROTHIAZIDE

Same manufacturer · Mylan Laboratories Limited, (Nashik FDF)

See all →

Same hazard · nitrosamine impurity

See all →