The Recall Desk
SevereFDA (Drugs)·D-0365-2019·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 labs confirmed the presence of the impurity N-nitrosodimethylamine (NDEA) above the interim 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 the presence of NDEA, a potential carcinogen, above the acceptable daily intake level represents a significant health risk, aligning with the 'Severe' criteria for significant injury or risk of harm.

Plain-English summary

Aurobindo Pharma USA Inc. is recalling 23,016 bottles of Valsartan and Hydrochlorothiazide tablets USP 320mg/12.5 mg, 90-count. The affected product is identified by NDC 65862-550-90 and includes five specific lot numbers: HRSA17033-A, HRSA17034-A, HRSA17035-A, HRSA17036-A, and HRSA17037-A, all with an expiration date of 10/2020.

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 detected levels of NDEA exceeded the interim acceptable daily intake level of 0.083 parts per million.

The product was distributed to 25 distributors and retail chains, which may have further distributed the medication throughout the United States. Consumers and healthcare providers should check their inventory for the specific lot numbers and NDC listed above. If the product is found, it should be returned to the pharmacy or distributor for a refund or replacement, and patients should consult their healthcare provider for alternative treatment options.

The recalled product

Product
VALSARTAN AND HYDROCHLOROTHIAZIDE (VALSARTAN AND HYDROCHLOROTHIAZIDE)
Brand
VALSARTAN AND HYDROCHLOROTHIAZIDE
Manufacturer
Aurobindo Pharma USA Inc.
Category
Drug — Prescription Drug
Hazard
Affected units
23,016

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 (6)

  • Lot # HRSA17033-A
  • exp. date 10/2020 Lot # HRSA17034-A
  • exp. date 10/2020 Lot # HRSA17035-A
  • exp. date 10/2020 Lot # HRSA17036-A
  • exp. date 10/2020 Lot # HRSA17037-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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