FDA Drug recall D-1043-2017

Divalproex Sodium Delayed Release Tablets, USP, 500 mg, a.) 100-count bottle (NDC 68382-033-01) b.) 500-count bottle (NDC 68382-033-05), Rx…

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, 500 mg, a.) 100-count bottle (NDC 68382-033-01) b.) 500-count bottle (NDC 68382-033-05), Rx… by Zydus Pharmaceuticals Usa, citing failed Dissolution Specifications.

Read the official FDA Drug notice

Agency	FDA Drug
Recall number	D-1043-2017
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, 500 mg, a.) 100-count bottle (NDC 68382-033-01) b.) 500-count bottle (NDC 68382-033-05), Rx only, manufactured by Cadila Healthcare Ltd, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals, Pennington, NJ 07054

Reason

Failed Dissolution Specifications

Identifiers

code_info	M603084 May-18 M603085 May-18 M603679 May-18 MR10030 Sep-17 MR10040 Sep-17 MR10103 Sep-17 MR10104 Sep-17 MR10259… M603084 May-18 M603085 May-18 M603679 May-18 MR10030 Sep-17 MR10040 Sep-17 MR10103 Sep-17 MR10104 Sep-17 MR10259 Sep-17 MR10262 Sep-17 MR10263 Sep-17 MR10413 Sep-17 MR10415 Sep-17 MR10416 Oct-17 MR10695 Oct-17 MR10696 Oct-17 MR10697 Oct-17 MR10698 Oct-17 MR10699 Oct-17 MR10927 Oct-17 MR10929 Oct-17 MR10930 Nov-17 MR11182 Nov-17 MR11184 Nov-17 MR11187 Oct-17 MR11188 Oct-17 MR11189 Nov-17 MR11190 Nov-17 MR11361 Nov-17 MR11362 Nov-17 MR11363 Nov-17 MR11364 Nov-17 MR11365 Nov-17 MR11673 Nov-17 MR11674 Nov-17 MR11675 Nov-17 MR11676 Nov-17 MR11677 Nov-17 MR11872 Nov-17 MR11873 Nov-17 MR11874 Nov-17 MR11875 Nov-17 MR11876 Nov-17 MR11877 Nov-17 MR11878 Nov-17 MR5992 May-17 MR6188 May-17 MR6189 May-17 MR6313 May-17 MR6314 Jun-17 MR6315 Jun-17 MR6316 Jun-17 MR6620 Jun-17 MR6621 Jun-17 MR6622 Jun-17 MR7031 Jun-17 MR7032 Jun-17 MR7033 Jun-17 MR7034 Jun-17 MR7035 Jun-17 MR7299 Jun-17 MR7300 Jun-17 MR7301 Jun-17 MR7303 Jun-17 MR7767 Jul-

code_info

M603084 May-18 M603085 May-18 M603679 May-18 MR10030 Sep-17 MR10040 Sep-17 MR10103 Sep-17 MR10104 Sep-17 MR10259…

M603084 May-18 M603085 May-18 M603679 May-18 MR10030 Sep-17 MR10040 Sep-17 MR10103 Sep-17 MR10104 Sep-17 MR10259 Sep-17 MR10262 Sep-17 MR10263 Sep-17 MR10413 Sep-17 MR10415 Sep-17 MR10416 Oct-17 MR10695 Oct-17 MR10696 Oct-17 MR10697 Oct-17 MR10698 Oct-17 MR10699 Oct-17 MR10927 Oct-17 MR10929 Oct-17 MR10930 Nov-17 MR11182 Nov-17 MR11184 Nov-17 MR11187 Oct-17 MR11188 Oct-17 MR11189 Nov-17 MR11190 Nov-17 MR11361 Nov-17 MR11362 Nov-17 MR11363 Nov-17 MR11364 Nov-17 MR11365 Nov-17 MR11673 Nov-17 MR11674 Nov-17 MR11675 Nov-17 MR11676 Nov-17 MR11677 Nov-17 MR11872 Nov-17 MR11873 Nov-17 MR11874 Nov-17 MR11875 Nov-17 MR11876 Nov-17 MR11877 Nov-17 MR11878 Nov-17 MR5992 May-17 MR6188 May-17 MR6189 May-17 MR6313 May-17 MR6314 Jun-17 MR6315 Jun-17 MR6316 Jun-17 MR6620 Jun-17 MR6621 Jun-17 MR6622 Jun-17 MR7031 Jun-17 MR7032 Jun-17 MR7033 Jun-17 MR7034 Jun-17 MR7035 Jun-17 MR7299 Jun-17 MR7300 Jun-17 MR7301 Jun-17 MR7303 Jun-17 MR7767 Jul-

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-1043-2017%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.