Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
RxRecalls Get alerts
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.

Cause type: Labeling / mix-up

Wrong label, wrong strength, mixed-up products, or packaging errors. One of the most dangerous causes - you can end up taking the wrong drug or the wrong dose. All labeling / mix-up recalls.

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.

Affected NDC 0245-0182-11

Compare with the code on your package — it is the most precise check available.

Drug: Divalproex

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 · FDA notice

Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.

Other Divalproex recalls

See all

Other recalls by Upsher Smith Laboratories, Inc.

All 2012 recalls
Class II · Moderate risk

Bumetanide Tablets

Failed impurities/ degradation specifications: Product is Out of Specification for an unspecified degradation product.

Terminated Impurity / degradation Upsher Smith Laboratories, Inc. NDC 0832-0542-11 D-0281-2019
Class II · Moderate risk

Bumetanide Tablets

Failed impurities/ degradation specifications: Product is Out of Specification for an unspecified degradation product.

Terminated Impurity / degradation Upsher Smith Laboratories, Inc. NDC 0832-0541-11 D-0280-2019
Class III · Low risk

Oxandrolone Tablets

Labeling: Missing Label; Three cases of product (total of 36 bottles) were packaged without the primary label on the bottle. The cases were, however, packaged in the correct finished product shipper, labeled with the correct shipper bar code label, sealed with tamper-evident tape and erroneously shipped to Upsher-Smith.

Terminated Labeling / mix-up Upsher Smith Laboratories, Inc. NDC 0245-0272-06 D-1255-2014