US Drug Recall Register
Class III · Low risk Terminated Initiated Dec 10, 2012 (14 years ago)

Divalproex Sodium Delayed-Release Tablets

Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.

Why it was recalled

Labeling: Label Error On Declared Strength; Some bottles of product were missing the color-coded strength on the primary display panel of the label.

What was recalled

Divalproex Sodium Delayed-Release Tablets, USP, 500 mg Valproic Acid Activity, 100-count tablets per bottle, Rx only, Manufactured by Upsher-Smith Laboratories, Inc., Minneapolis, MN 55447, NDC 0245-0182-11.

Recalling firm
Upsher Smith Laboratories, Inc.
NDC code
0245-0182-11
Origin
MN, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-127-2013

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

Other Divalproex recalls

See all
Class II · Moderate risk Terminated

Divalproex Sodium Delayed-Release Tablets

Reason Failed Dissolution Specifications: Failure occurred during routine stability testing of dissolution test.

Sun Pharmaceutical Industries INC NDC 62756-798-88 D-1291-2022
Class II · Moderate risk Terminated

Divalproex Sodium Extended-Release Tablets

Reason cGMP deviations: Product was exposed above 50% relative humidity levels during packaging operations.

Major Pharmaceuticals NDC 0904-6363-61 D-1583-2019