Class II · Moderate risk Ongoing
Divalproex Sodium Delayed-Release Tablets, USP, 500 mg, 500 Tablets bottles, Rx only, Distributed by: Bionpharma Inc., Princeton…
Reason Presence of Foreign Tablets/Capsules
Is Divalproex recalled?
16 FDA recalls mention Divalproex. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Divalproex.
Class II · Moderate risk Terminated
Divalproex Sodium Extended-release Tablets, USP 250 mg, Rx Only, 100 tablets, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd…
Reason Failed dissolution specifications
Class II · Moderate risk Terminated
Divalproex Sodium Extended Release Tablets, USP, 250 mg, packaged in 100-count bottle, Rx only, Manufactured by: Amneal…
Reason Failed dissolution specifications.
Class II · Moderate risk Terminated
Divalproex Sodium Delayed-Release Tablets, USP 500mg, Rx Only, 100 Tablets, Distributed by: Sun Pharmaceutical Industries, Inc…
Reason Failed Dissolution Specifications: Failure occurred during routine stability testing of dissolution test.
Class II · Moderate risk Terminated
DIVALPROEX SODIUM EXTENDED-RELEASE TABLETS, USP Tablets, 250 mg, 100 count-unit dose carton, RX only, Manufactured by Dr. Reddy's…
Reason cGMP deviations: Product was exposed above 50% relative humidity levels during packaging operations.
Class II · Moderate risk Terminated
Divalproex Sodium Extended-Release Tablets, USP, 250 mg a) 100-count bottle (NDC 55111-0533-01), b) 500-count bottle (NDC…
Reason cGMP deviations: Product was exposed above 50% relative humidity levels during packaging operations.
Class II · Moderate risk Terminated
Divalproex Sodium Extended-release Tablets, USP 250 mg, 100-count bottle, Rx only, Mfd.By: Dr. Reddy's Laboratories Limited…
Reason Failed Dissolution Specifications: Out of specification results observed for high dissolution.
Class II · Moderate risk Terminated
Divalproex Sodium Delayed Release Tablets USP, 500 mg, 100-count bottle, RX Only, Manufactured by: Unichem Laboratories Ltd. Ind…
Reason Cross Contamination With Other Products: metronidazole powder was found in one bottle of Divalproex Sodium.
Class II · Moderate risk Terminated
Divalproex Sodium Delayed Release Tablets, USP, 500 mg, a.) 100-count bottle (NDC 68382-033-01) b.) 500-count bottle (NDC…
Reason Failed Dissolution Specifications
Class II · Moderate risk Terminated
Divalproex Sodium Delayed Release Tablets, USP, 250 mg 100-count bottle (NDC 68382-032-01), b.) 500-count bottle (NDC…
Reason Failed Dissolution Specifications
Class II · Moderate risk Terminated
Divalproex Sodium Delayed Release Tablets, USP, 125 mg, 100-count bottle Rx only, Manufactured by Cadila Healthcare Ltd…
Reason Failed Dissolution Specifications
Class II · Moderate risk Terminated
Divalproex Sodium Delayed Release Tablets, USP, 500 mg, a) 100 count (NDC 68382-033-01) and b) 500 count (NDC 68382-033-05)…
Reason Failed Dissolution Specifications; 9 month long term stability
Class III · Low risk Terminated
Divalproex Sodium Delayed-release Tablets USP, RX, 250 mg, 100 count bottles, Manufactured in Israel by: TEVA PHARMACEUTICALS…
Reason Failed Tablet/Capsule Specifications
Class II · Moderate risk Terminated
Divalproex Sodium Extended-Release Tablets, USP, 500 mg, 100 count bottles, Rx Only, Mfd. By. Dr. Reddy's Laboratories Limited…
Reason Failed Dissolution Specifications; exceeded specification at the 9 hour time point
Class II · Moderate risk Terminated
Divalproex Sodium Extended-Release Tablets, USP, (valproic acid activity), 250 mg, 100 count (NDC 55111-533-01) and 500 count…
Reason Failed Dissolution Specifications; exceeded specification at the 9 hour time point
Class III · Low risk Terminated
Divalproex Sodium Delayed-Release Tablets, USP, 500 mg Valproic Acid Activity, 100-count tablets per bottle, Rx only…
Reason 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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