Divalproex Sodium Tablets (Zydus) – Failed Dissolution (2017)
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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
Brand
Zydus Pharmaceuticals USA Inc
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
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-17 MR8223 Jul-17 MR8224 Jul-17 MR8225 Jul-17 MR8248 Jul-17 MR8249 Jul-17 MR8578 Aug-17 MR8579 Aug-17 MR8580 Aug-17 MR8581 Aug-17 MR8888 Aug-17 MR8889 Aug-17 MR8890 Aug-17 MR8891 Aug-17 MR8894 Aug-17 MR9012 Aug-17 MR9013 Sep-17 MR9015 Sep-17 MR9016 Sep-17 MR9414 Aug-17 MR9415 Aug-17 MR9416 Sep-17 MS1246 Dec-17 MS1247 Dec-17 MS1248 Dec-17 MS1249 Dec-17 MS1250 Dec-17 MS1251 Dec-17 MS1252 Dec-17 MS1355 Dec-17 MS1356 Dec-17 MS1357 Jan-18 MS1358 Dec-17 MS2490 Feb-18 MS2491 Feb-18 MS2492 Feb-18
Zydus Pharmaceuticals USA Inc is recalling Divalproex Sodium Delayed Release Tablets, USP, 500 mg, a.) 100-count bottle (NDC 68382-033-01) b.) due to Failed Dissolution Specifications. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Failed Dissolution Specifications
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026