The Recall Desk
SevereFDA (Drugs)·D-0369-2019·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 N-nitrosodimethylamine (NDEA) above the acceptable daily intake level.

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 recall is classified as FDA Class II and involves a known carcinogenic impurity (NDEA) exceeding safety limits, which aligns with the rubric criteria for Severe severity.

Plain-English summary

Aurobindo Pharma USA Inc. is recalling 53,064 bottles of Valsartan and Hydrochlorothiazide tablets USP 160 mg/25 mg, 90-count. The affected product is identified by NDC 65862-549-90 and includes ten specific lot numbers with expiration dates ranging from August 2020 to December 2020. The product was distributed to 25 distributors and retail chains, which may have further distributed the medication throughout the United States.

The recall was initiated because FDA laboratory testing confirmed the presence of the impurity 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. This recall is classified as FDA Class II.

Patients currently taking these specific lots of Valsartan and Hydrochlorothiazide should contact their healthcare provider for guidance on alternative treatment options. Consumers should check their medication bottles for the NDC number and lot numbers listed in this 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
53,064

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 # HVSB17023-A
  • exp. date 08/2020 Lot # HVSB17036-A
  • exp. date 11/2020 Lot # HVSB17037-A
  • exp. date 11/2020 Lot # HVSB17038-A
  • exp. date 11/2020 Lot # HVSB17039-A
  • exp. date 11/2020 Lot # HVSB17040-B
  • exp. date 11/2020 Lot # HVSB18001-A
  • exp. date 12/2020 Lot # HVSB18002-A
  • exp. date 12/2020 Lot # HVSB18003-A
  • exp. date 12/2020 Lot # HVSB18004-A
  • exp. date 12/2020

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 · ndea impurity

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