The Recall Desk
SevereFDA (Drugs)·D-0367-2019·Announced 2019-01-23

Aurobindo Recalls Valsartan and Hydrochlorothiazide Tablets Due to NDEA Impurity

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

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 agency classification is FDA Class II, and the presence of NDEA, a potential carcinogen, above acceptable levels constitutes a significant health risk warranting a Severe rating.

Plain-English summary

Aurobindo Pharma USA Inc. is recalling Valsartan and Hydrochlorothiazide tablets USP 320 mg/25 mg, 90-count bottles. The recall involves 111,239 bottles of the prescription medication, which was distributed to 25 distributors and retail chains who may have further distributed the product throughout the United States.

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. FDA laboratory testing confirmed the presence of the impurity N-nitrosodimethylamine (NDEA) in the active pharmaceutical ingredient (API) used to manufacture the product. The levels of NDEA were found to be above the interim acceptable daily intake level of 0.083 parts per million.

Patients currently taking this medication should consult their healthcare provider for guidance on alternative treatments. The specific lot numbers and expiration dates affected are listed in the official recall documentation.

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
111,239

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 (20)

  • Lot # HTSB17049-A
  • exp. date 08/2020 Lot # HTSB17054-A
  • exp. date 10/2020 Lot # HTSB17055-A
  • exp. date 10/2020 Lot # HTSB17056-A
  • exp. date 10/2020 Lot # HTSB17057-A
  • exp. date 10/2020 Lot # HTSB17058-A
  • exp. date 10/2020 Lot # HTSB17059-A
  • exp. date 10/2020 Lot # HTSB17060-A
  • exp. date 10/2020 Lot # HTSB17062-A
  • exp. date 10/2020 Lot # HTSB17066-A
  • exp. date 10/2020 Lot # HTSB17067-A
  • exp. date 11/2020 Lot # HTSB17068-A
  • exp. date 11/2020 Lot # HTSB17069-A
  • exp. date 11/2020 Lot # HTSB18001-A
  • exp. date 12/2020 Lot # HTSB18002-A
  • exp. date 12/2020 Lot # HTSB18003-A
  • exp. date 12/2020 Lot # HTSB18004-A
  • exp. date 12/2020 Lot # HTSB18005-A
  • exp. date 12/2020 Lot # HTSB18006-A
  • exp. date 12/2020 Lot # HTSB18007-A

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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