The Recall Desk
ModerateFDA (Drugs)·D-1106-2018·Announced 2018-08-29

Jubilant Cadista Recalls Valsartan Tablets Due to Incorrect Excipient Grade

Jubilant Cadista Pharmaceuticals is recalling 7,048 bottles of Valsartan 320 mg 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 typically corresponds to a score of 1 or 2. Given the potential for an incorrect excipient grade, a score of 2 (Moderate) is appropriate as it represents a low-risk contamination or labeling issue that is unlikely to cause adverse health consequences.

Plain-English summary

Jubilant Cadista Pharmaceuticals, Inc. is recalling 7,048 bottles of Valsartan Tablets USP, 320 mg, 90-count. The recall involves specific lots with expiration dates of 09/2019 and 10/2019. The product is a prescription-only medication manufactured by Jubilant Generics Ltd in India and marketed by Jubilant Cadista Pharmaceuticals in Salisbury, MD.

The recall was initiated because there is a potential that an incorrect grade of excipient was used during the manufacturing process. The affected product was distributed throughout the United States to wholesalers and retailers.

Consumers who have this medication should contact their healthcare provider or pharmacist for guidance on how to proceed. The recall is classified as Class III by the FDA, indicating that the use of or exposure to the product is not likely to cause adverse health consequences.

The recalled product

Product
VALSARTAN (VALSARTAN)
Brand
VALSARTAN
Manufacturer
Jubilant Cadista Pharmaceuticals, Inc.
Category
Drug — Prescription Medication
Hazard
Affected units
7,048

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 #: VR417062A
  • Exp. 09/2019
  • VR417063A
  • VR417064A
  • Exp. 10/2019

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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