FDA Drug recall D-1042-2017

Divalproex Sodium Delayed Release Tablets, USP, 250 mg 100-count bottle (NDC 68382-032-01), b.) 500-count bottle (NDC 68382-032-05),Rx only…

FDA Drug
Class II
terminated
Published 2017-08-09

On 2017-08-09 the FDA classified a Class II recall of Divalproex Sodium Delayed Release Tablets, USP, 250 mg 100-count bottle (NDC 68382-032-01), b.) 500-count bottle (NDC 68382-032-05),Rx only… by Zydus Pharmaceuticals Usa, citing failed Dissolution Specifications.

Read the official FDA Drug notice

Agency	FDA Drug
Recall number	D-1042-2017
Classification	Class II
Status	terminated
Initiated	2017-05-10
Published	2017-08-09
Last updated	2026-09-13 11:51 UTC
Company	Zydus Pharmaceuticals Usa
Distribution	US

Product

Divalproex Sodium Delayed Release Tablets, USP, 250 mg 100-count bottle (NDC 68382-032-01), b.) 500-count bottle (NDC 68382-032-05),Rx only, Manufactured by Cadila Healthcare Ltd, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals, Pennington, NJ 07054

Reason

Failed Dissolution Specifications

Identifiers

code_info	MR5990 May-17 MR5991 May-17 MR7294 Jun-17 MR7295 Jun-17 MR7296 Jun-17 MR7297 Jun-17 MR7298 Jun-17 MR7603 Jun-17… MR5990 May-17 MR5991 May-17 MR7294 Jun-17 MR7295 Jun-17 MR7296 Jun-17 MR7297 Jun-17 MR7298 Jun-17 MR7603 Jun-17 MR7604 Jun-17 MR7605 Jun-17 MR7606 Jul-17 MR7607 Jul-17 MR8575 Aug-17 MR8576 Aug-17 MR8577 Aug-17 MR8882 Aug-17 MR8883 Aug-17 MR8884 Aug-17 MR8885 Aug-17 MR8886 Aug-17 MR9417 Aug-17 MR9418 Aug-17 MR9419 Aug-17 MR9499 Aug-17 MR9500 Aug-17 MR9501 Sep-17 MR9502 Sep-17 MR9601 Sep-17 MR9602 Sep-17 MR9805 Sep-17 MR9806 Sep-17 MR9807 Sep-17 MR9808 Sep-17 MR10536 Oct-17 MR10537 Oct-17 MR10538 Oct-17 MR10539 Oct-17 MR10540 Oct-17 MR10916 Oct-17 MR10918 Oct-17 MR10919 Nov-17 MR10920 Nov-17 MR10921 Nov-17 MR11366 Nov-17 MR11367 Nov-17 MR11368 Nov-17 MR11369 Nov-17 MR11370 Nov-17 MR11671 Nov-17 MR11672 Nov-17 MR11682 Nov-17 MR11682 Nov-17 MS1360 Dec-17 MS1361 Dec-17 MS1362 Dec-17 MS1363 Dec-17 MS1364 Dec-17 M600386 Feb-18 M600387 Feb-18 M600388 Feb-18 M602270 Mar-18 M602272 Apr-18

code_info

MR5990 May-17 MR5991 May-17 MR7294 Jun-17 MR7295 Jun-17 MR7296 Jun-17 MR7297 Jun-17 MR7298 Jun-17 MR7603 Jun-17…

MR5990 May-17 MR5991 May-17 MR7294 Jun-17 MR7295 Jun-17 MR7296 Jun-17 MR7297 Jun-17 MR7298 Jun-17 MR7603 Jun-17 MR7604 Jun-17 MR7605 Jun-17 MR7606 Jul-17 MR7607 Jul-17 MR8575 Aug-17 MR8576 Aug-17 MR8577 Aug-17 MR8882 Aug-17 MR8883 Aug-17 MR8884 Aug-17 MR8885 Aug-17 MR8886 Aug-17 MR9417 Aug-17 MR9418 Aug-17 MR9419 Aug-17 MR9499 Aug-17 MR9500 Aug-17 MR9501 Sep-17 MR9502 Sep-17 MR9601 Sep-17 MR9602 Sep-17 MR9805 Sep-17 MR9806 Sep-17 MR9807 Sep-17 MR9808 Sep-17 MR10536 Oct-17 MR10537 Oct-17 MR10538 Oct-17 MR10539 Oct-17 MR10540 Oct-17 MR10916 Oct-17 MR10918 Oct-17 MR10919 Nov-17 MR10920 Nov-17 MR10921 Nov-17 MR11366 Nov-17 MR11367 Nov-17 MR11368 Nov-17 MR11369 Nov-17 MR11370 Nov-17 MR11671 Nov-17 MR11672 Nov-17 MR11682 Nov-17 MR11682 Nov-17 MS1360 Dec-17 MS1361 Dec-17 MS1362 Dec-17 MS1363 Dec-17 MS1364 Dec-17 M600386 Feb-18 M600387 Feb-18 M600388 Feb-18 M602270 Mar-18 M602272 Apr-18

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1042-2017%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.