The Recall Desk
LowFDA (Drugs)·D-1105-2018·Announced 2018-08-29

Jubilant Cadista Recalls Valsartan Tablets Due to Potential Excipient Error

Jubilant Cadista Pharmaceuticals is recalling 18,947 bottles of Valsartan 160 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 recall as Class III, which by definition indicates that use of or exposure to the violative product is not likely to cause adverse health consequences, aligning with the 'Low' severity criteria for documentation or minor issues.

Plain-English summary

Jubilant Cadista Pharmaceuticals, Inc. is recalling 18,947 bottles of Valsartan Tablets USP, 160 mg, 90-count. The recall is due to a potential use of an incorrect grade of excipient during the manufacturing process. The affected product is NDC 59746-362-90, manufactured by Jubilant Generics Ltd in India and marketed by Jubilant Cadista Pharmaceuticals, Inc. in Salisbury, MD.

The affected lots are VR317040A, VR317041A, VR317042A, and VR317043A, all with an expiration date of 08/2019. The product was distributed throughout the United States to wholesalers and retailers. The FDA 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 and healthcare professionals should check their inventory for the specific lot numbers and expiration dates listed above. If the product matches the recalled description, it should be returned to the pharmacy or point of purchase for a refund or replacement. Patients should consult their healthcare provider for alternative treatment options if they have been prescribed this specific medication.

The recalled product

Product
VALSARTAN (VALSARTAN)
Brand
VALSARTAN
Manufacturer
Jubilant Cadista Pharmaceuticals, Inc.
Category
Drug — Prescription Drug
Hazard
Affected units
18,947

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 (5)

  • Lot #: VR317040A
  • VR317041A
  • VR317042A
  • VR317043A
  • 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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