Class III โ€” Low Risk

Low risk โ€” use of or exposure to this product is not likely to cause adverse health consequences.

Divalproex Sodium Delayed-Release Tablets Recalled by Upsher Smith Laboratories, Inc. Due to Labeling: Label Error On Declared Strength; Some bottles...

Date: December 10, 2012
Company: Upsher Smith Laboratories, Inc.
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Upsher Smith Laboratories, Inc. directly.

Affected Products

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.

Quantity: 11,316 bottles

Why Was This 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.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Upsher Smith Laboratories, Inc.

Upsher Smith Laboratories, Inc. has 6 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report