FDAClass IIIJune 13, 2018

Valsartan Tablets USP recall

Valsartan Tablets USP, 320 mg, 90 tablet, Rx Only, Manufactured by: Jubilant Generics Ltd. Roorkee - 247661, India, Marketed by: Jubilant Cadista…

Why was Valsartan Tablets USP recalled?

Incorrect/Undeclared excipient: Product batches were released into commercial distribution with a larger size grade of excipient (Crospovidone).

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot #: VR417065A, VR417066A, Exp 10/2019

Product
Valsartan Tablets USP, 320 mg, 90 tablet, Rx Only, Manufactured by: Jubilant Generics Ltd. Roorkee - 247661, India, Marketed by: Jubilant Cadista…
Recalling firm
Jubilant Cadista Pharmaceuticals, Inc.
Quantity
2,328 bottles (Lot VR417065A) and 2,352 bottles (Lot VR417066A)
Distribution
IN, MI, MS, NC, NJ, NY and OH
Recall date
June 13, 2018
Classification
Class III
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls