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 (NDC 68382-033-01) and b) 500 count (NDC 68382-033-05) bottles, Rx only, manufactured by Cadila Healthcare Ltd, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals, Pennington, NJ
Brand
Zydus Pharmaceuticals USA Inc
Lot Codes / Batch Numbers
a) MR8221, MR8222 exp 7/31/2017, MR10260, exp 9/30/2017, MR10926, exp 10/31/2017, b) MR6187, exp 5/31/2017, MR7302, exp 6/30/2017, MR7768, MR7769, exp 7/31/2017, MR8247, exp 7/31/2017, MR8887, MR8892, MR8893 exp 8/31/2017, MR9014, MR10414 exp 9/30/2017, MR10928, exp 10/31/2017, MR11183, MR11185, MR11186, exp 11/30/2017
Products Sold
a) MR8221, MR8222 exp 7/31/2017; MR10260, exp 9/30/2017; MR10926, exp 10/31/2017; b) MR6187, exp 5/31/2017; MR7302, exp 6/30/2017; MR7768, MR7769, exp 7/31/2017; MR8247, exp 7/31/2017; MR8887, MR8892, MR8893 exp 8/31/2017; MR9014, MR10414 exp 9/30/2017; MR10928, exp 10/31/2017; MR11183, MR11185, MR11186, exp 11/30/2017
Zydus Pharmaceuticals USA Inc is recalling Divalproex Sodium Delayed Release Tablets, USP, 500 mg, a) 100 count (NDC 68382-033-01) and b) 500 due to Failed Dissolution Specifications; 9 month long term stability. 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; 9 month long term stability
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