The Recall Desk
SevereFDA (Drugs)·D-0362-2019·Announced 2019-01-23

Aurobindo Recalls Amlodipine and Valsartan Tablets Due to NDEA Impurity

Aurobindo Pharma USA Inc. is recalling specific lots of Amlodipine and Valsartan 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 recall is classified as FDA Class II, which corresponds to a Severe severity score under the rubric for significant potential health risks.

Plain-English summary

Aurobindo Pharma USA Inc. is recalling Amlodipine and Valsartan Tablets USP 10 mg/160 mg, 30-count bottles. The recall involves 60,417 bottles from 14 specific lots. The product was distributed to 25 distributors and retail chains, which 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 detected levels of NDEA exceeded the interim acceptable daily intake level of 0.083 parts per million.

Consumers and healthcare providers should stop using the affected lots and contact their healthcare provider for guidance on alternative medications. The affected lots are identified by specific lot numbers and expiration dates listed in the recall notice.

The recalled product

Product
AMLODIPINE AND VALSARTAN (AMLODIPINE AND VALSARTAN)
Brand
AMLODIPINE AND VALSARTAN
Manufacturer
Aurobindo Pharma USA Inc.
Category
Drug — Prescription Drug
Hazard
Affected units
60,417

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 (15)

  • Lot # VFSA17008-A
  • exp. 10/2019 Lot # VFSA17010-A
  • exp. 10/2019 Lot # VFSA18002-A
  • exp. 01/2020 Lot# VFSA18003-A
  • exp. 01/2020 Lot # VFSA18007-A
  • exp. 03/2020 Lot # VFSA18008-A
  • exp. 03/2020 Lot # VKSA17008-A
  • exp. 05/2019 Lot # VFSA17009-A
  • exp. 10/2019 Lot # VKSA17014-A
  • exp. 10/2019 Lot # VKSA17015-A
  • exp. 10/2019 Lot # VKSA17016-A
  • exp. 10/2019 Lot # VKSA17017-A
  • exp. 10/2019 Lot # VKSA18002-A
  • exp. 01/2020 Lot # VKSA18004-A
  • exp. 01/2020

UPCs (2)

  • 0365862739308
  • 0365862737304

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 →

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Same brand · AMLODIPINE AND VALSARTAN

Same manufacturer · Aurobindo Pharma USA Inc.

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Same hazard · nitrosamine impurity

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