The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0327-2019·Announced 2018-12-19

Mylan Recalls Valsartan Tablets Due to NDEA Impurity

Mylan is recalling Valsartan 320 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 FDA classified this recall as Class II. Per the rubric, an FDA Class II recall involving a significant health hazard (NDEA impurity) corresponds to a severity score of 4 (Severe).

Plain-English summary

Mylan Laboratories Limited is recalling Valsartan Tablets, USP 320 mg, 90-count bottles. The recall involves 129,754 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 has classified this recall as Class II.

Consumers should check their medication for the specific lot numbers listed in the recall notice. If the medication matches the recalled lots, 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
129,754

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

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 →

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