The Recall Desk
ModerateFDA (Drugs)·D-1104-2018·Announced 2018-08-29

Jubilant Cadista Recalls Valsartan Tablets Due to Potential Excipient Error

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

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class III, which indicates a low risk of adverse health consequences. The hazard involves a potential manufacturing error regarding an excipient grade, which is a quality control issue rather than a direct, high-risk contamination or mislabeling of a common allergen.

Plain-English summary

Jubilant Cadista Pharmaceuticals, Inc. is recalling Valsartan Tablets USP, 80 mg, 90-count bottles. The recall involves 9,552 bottles of the medication, which is prescribed for the treatment of high blood pressure. The product was distributed throughout the United States to wholesalers and retailers.

The recall was initiated due to a potential use of an incorrect grade of excipient during the manufacturing process. An excipient is an inactive ingredient added to a drug product to aid in its formulation or stability. The use of an incorrect grade may affect the quality or safety of the medication, although the specific nature of the defect is not detailed in the source text.

Consumers who have this specific product should stop using it and contact their healthcare provider or pharmacist for guidance. The affected product is identified by Lot # VR217013A with an expiration date of 08/2019. The NDC number for the recalled 90-count bottle is 59746-361-90.

The recalled product

Product
VALSARTAN (VALSARTAN)
Brand
VALSARTAN
Manufacturer
Jubilant Cadista Pharmaceuticals, Inc.
Category
Drug — Prescription Drug
Hazard
Affected units
9,552

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 (2)

  • Lot #: VR217013A
  • 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.

See all →

Same hazard · manufacturing error

See all →