Divalproex Sodium Delayed-Release Tablets
Presence of Foreign Tablets/Capsules
Yes — there is an active recall. 1 ongoing FDA recall mention Divalproex (16 total). Check the affected lots below.
Most common reason: Dissolution failure (10 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Divalproex. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Presence of Foreign Tablets/Capsules
Failed dissolution specifications
Failed dissolution specifications.
Failed Dissolution Specifications: Failure occurred during routine stability testing of dissolution test.
cGMP deviations: Product was exposed above 50% relative humidity levels during packaging operations.
cGMP deviations: Product was exposed above 50% relative humidity levels during packaging operations.
Failed Dissolution Specifications: Out of specification results observed for high dissolution.
Cross Contamination With Other Products: metronidazole powder was found in one bottle of Divalproex Sodium.
Failed Dissolution Specifications
Failed Dissolution Specifications
Failed Dissolution Specifications
Failed Dissolution Specifications; 9 month long term stability
Failed Tablet/Capsule Specifications
Failed Dissolution Specifications; exceeded specification at the 9 hour time point
Failed Dissolution Specifications; exceeded specification at the 9 hour time point
Labeling: Label Error On Declared Strength; Some bottles of product were missing the color-coded strength on the primary display panel of the label.
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