FDAClass IIFebruary 27, 2019

Divalproex Sodium Extended-release Tablets recall: Failed Dissolution

Divalproex Sodium Extended-release Tablets, USP 250 mg, 100-count bottle, Rx only, Mfd.By: Dr. Reddy's Laboratories Limited Bachupally - 500 090 India…

Why was Divalproex Sodium Extended-release Tablets recalled?

Failed Dissolution Specifications: Out of specification results observed for high dissolution.

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 #: C802676, Exp 03/20

Product
Divalproex Sodium Extended-release Tablets, USP 250 mg, 100-count bottle, Rx only, Mfd.By: Dr. Reddy's Laboratories Limited Bachupally - 500 090 India…
Recalling firm
Dr. Reddy's Laboratories, Inc.
Quantity
10,656 bottles
Distribution
U.S.A. Nationwide
Recall date
February 27, 2019
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls