The Recall Desk
Agency classClass IIIOur severity:LowFDA (Drugs)·D-0876-2018·Announced 2018-06-13

Jubilant Cadista Recalls Valsartan Tablets Due to Incorrect Excipient Size

Jubilant Cadista Pharmaceuticals is recalling specific lots of Valsartan 320 mg tablets because they were released with an incorrect size grade of the excipient Crospovidone.

The agency’s classification

FDA (Drugs): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 1/5 (Low).

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

Our severity reasoning: The recall is classified as FDA Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences.

Plain-English summary

Jubilant Cadista Pharmaceuticals, Inc. is recalling Valsartan Tablets USP, 320 mg, 90 tablet bottles. The recall involves 2,328 bottles from Lot VR417065A and 2,352 bottles from Lot VR417066A, both with an expiration date of 10/2019. The product is marketed under NDC 59746-363-90 and was manufactured by Jubilant Generics Ltd. in India.

The recall was initiated because the product batches were released into commercial distribution with a larger size grade of the excipient Crospovidone than intended. This is classified as an FDA Class III recall, indicating that use of or exposure to the violative product is not likely to cause adverse health consequences.

The affected product was distributed in Indiana, Michigan, Mississippi, North Carolina, New Jersey, New York, and Ohio. Patients should consult their healthcare provider or pharmacist for guidance on alternative medications or further instructions regarding the recalled product.

The recalled product

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

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 #: VR417065A
  • VR417066A
  • Exp 10/2019

UPCs (8)

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

Distribution

Distributed in 7 states:

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