The Recall Desk
LowFDA (Drugs)·D-1103-2018·Announced 2018-08-29

Jubilant Cadista Recalls Valsartan Tablets Due to Incorrect Excipient Grade

Jubilant Cadista Pharmaceuticals is recalling specific lots of Valsartan 40 mg tablets because an incorrect grade of excipient may have been used during manufacturing.

What this means for you

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The FDA classified this as a Class III recall, which by definition is unlikely to cause adverse health consequences, fitting the 'Low' severity criteria for documentation or minor quality issues.

Plain-English summary

Jubilant Cadista Pharmaceuticals, Inc. is recalling Valsartan Tablets USP, 40 mg, 30-count bottles. The recall involves 10,577 bottles with lot numbers VR117014A and VR117015A, which have an expiration date of 08/2019. The product was distributed throughout the United States to wholesalers and retailers.

The recall was initiated because there is a potential that an incorrect grade of excipient was used during the manufacturing process. The agency has classified this recall as Class III, indicating that use of, or exposure to, the violative product is not likely to cause adverse health consequences.

Consumers who have these specific lot numbers should stop using the medication and contact their healthcare provider or pharmacist for guidance on obtaining a replacement. The product is prescription-only, so patients should not attempt to self-manage the switch without professional advice.

The recalled product

Product
VALSARTAN (VALSARTAN)
Brand
VALSARTAN
Manufacturer
Jubilant Cadista Pharmaceuticals, Inc.
Category
Drug — Prescription Medication
Hazard
Affected units
10,577

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 (3)

  • Lot #: VR117014A
  • VR117015A
  • Exp. 08/2019

UPCs (8)

  • 0359746363321
  • 0359746363307
  • 0359746361037
  • 0359746362034
  • 0359746360306
  • 0359746360030
  • 0359746361303
  • 0359746362300

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 4 recalled by Jubilant Cadista Pharmaceuticals, 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 4 products in this recall →

Related recalls

Same brand · VALSARTAN

Same manufacturer · Jubilant Cadista Pharmaceuticals, Inc.

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Same hazard · incorrect excipient

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