The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0316-2019·Announced 2018-12-19

Mylan Recalls Valsartan Tablets Due to NDEA Impurity

Mylan Pharmaceuticals is recalling specific lots of Valsartan 320 mg tablets because FDA labs confirmed the presence 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 and involves NDEA, a known carcinogenic impurity, which aligns with the rubric criteria for Severe severity involving significant health risks or Class II classifications with potential for serious harm.

Plain-English summary

Mylan Pharmaceuticals Inc. is recalling 25,147 bottles of Valsartan Tablets, USP, 320 mg, 90-count. The affected product is a prescription-only medication manufactured in India for Mylan Pharmaceuticals, Inc., located in Morgantown, WV. The specific NDC for the recalled product is 0378-5815-77.

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. FDA laboratory testing confirmed the presence of N-nitrosodiethylamine (NDEA), an impurity, in the active pharmaceutical ingredient (API) used to manufacture the product. The agency has classified this recall as Class II.

The affected lots are # 3081499 (exp. 3/2020), # 3080009 (exp. 2/2020), # 3080010 (exp. 2/2020), and # 3079205 (exp. 1/2020). The product was distributed throughout the United States. Consumers and healthcare providers should check their medication bottles for these specific lot numbers and expiration dates. If the product matches the recalled description, they should stop using it and contact their healthcare provider or pharmacist for guidance on alternative treatment options.

The recalled product

Product
VALSARTAN (VALSARTAN)
Brand
VALSARTAN
Manufacturer
Mylan Pharmaceuticals Inc.
Category
Drug — Prescription Medication
Hazard
Affected units
25,147

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 (5)

  • Lot # 3081499
  • exp. date 3/2020 Lot # 3080009
  • exp. date 2/2020 Lot # 3080010
  • exp. date 2/2020 Lot # 3079205
  • exp. date 1/2020

UPCs (4)

  • 0303785815778
  • 0303785813774
  • 0303785807933
  • 0303785814771

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 8 recalled by Mylan Pharmaceuticals Inc. 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 8 products in this recall →

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