The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0325-2019·Announced 2018-12-19

Mylan Recalls Valsartan Tablets Due to Trace NDEA Impurity

Mylan is recalling specific lots of Valsartan 80 mg tablets because FDA analysis found trace amounts of the impurity N-nitrosodiethylamine (NDEA).

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. 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 potential health risks.

Plain-English summary

Mylan Laboratories Limited is recalling Valsartan Tablets, USP 80 mg, 90-count bottles. The recall involves 119,761 HDPE bottles with NDC 0378-5813-77 and specific lot numbers: 3065445, 3074880, 3074883, 3086688, 3086689, and 3086710. The product was distributed throughout the United States to several major distributors, 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. This finding represents a Good Manufacturing Practice (GCMP) deviation.

Consumers and healthcare providers should check their medication bottles for the affected lot numbers and NDC code. If the medication matches the recalled description, patients should contact their healthcare provider or pharmacist for guidance on alternative treatment options.

The recalled product

Product
VALSARTAN (VALSARTAN)
Brand
VALSARTAN
Manufacturer
Mylan Laboratories Limited, (Nashik FDF)
Category
Drug — Prescription Medication
Hazard
Affected units
119,761

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 (6)

  • Lot Numbers: 3065445
  • 3074880
  • 3074883
  • 3086688
  • 3086689
  • 3086710

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 →

Similar recalls