The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0366-2019·Announced 2019-01-23

Aurobindo Recalls Valsartan and Hydrochlorothiazide Tablets Due to NDEA Impurity

Aurobindo Pharma USA Inc. is recalling specific lots of Valsartan and Hydrochlorothiazide tablets because FDA testing found the impurity NDEA above acceptable levels.

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 the presence of NDEA, a known carcinogen, above acceptable limits in a prescription drug constitutes a significant health risk warranting a Severe rating.

Plain-English summary

Aurobindo Pharma USA Inc. is recalling 92,616 bottles of Valsartan and Hydrochlorothiazide tablets USP 160mg/12.5 mg. The affected product is a prescription medication manufactured in Dayton, New Jersey, and distributed to 25 distributors and retail chains across the United States.

The recall was initiated because FDA laboratory testing confirmed the presence of N-nitrosodimethylamine (NDEA) in the active pharmaceutical ingredient (API) used to manufacture the product. The detected levels of NDEA exceeded the interim acceptable daily intake level of 0.083 parts per million. The agency has classified this recall as Class II.

Patients currently taking this medication should contact their healthcare provider for guidance on alternative treatments. Consumers should check their medication bottles for the specific lot numbers and expiration dates listed in the official recall notice to determine if their product is affected.

The recalled product

Product
VALSARTAN AND HYDROCHLOROTHIAZIDE (VALSARTAN AND HYDROCHLOROTHIAZIDE)
Brand
VALSARTAN AND HYDROCHLOROTHIAZIDE
Manufacturer
Aurobindo Pharma USA Inc.
Category
Drug — Prescription Medication
Hazard
Affected units
92,616

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 (11)

  • Lot # HTSA17033-A
  • exp. date 10/2020 Lot # HTSA17034-A
  • exp. date 10/2020 Lot # HTSA17035-A
  • exp. date 10/2020 Lot # HTSA17036-A
  • exp. date 10/2020 Lot # HTSA17040-A
  • exp. date 10/2020 Lot # HTSA17041-A
  • exp. date 11/2020 Lot # HTSA17042-A
  • exp. date 11/2020 Lot # HTSA17043-A
  • exp. date 11/2020 Lot # HTSA17037-A
  • exp. date 10/2020 Lot # HTSA17039-A
  • exp. date 10/2020

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 10 recalled by Aurobindo Pharma USA 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 10 products in this recall →

Related recalls

Same brand · VALSARTAN AND HYDROCHLOROTHIAZIDE

Same manufacturer · Aurobindo Pharma USA Inc.

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Same hazard · nde contamination

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