# FDA recall D-127-2013

> **Upsher Smith Laboratories, Inc.** · Class III · drug recall initiated 2012-12-10.

## Product

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.

## Reason for recall

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

## Distribution

Nationwide and Puerto Rico

## Key facts

- **Recall number:** D-127-2013
- **Recalling firm:** Upsher Smith Laboratories, Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2012-12-10
- **Report date:** 2013-01-23
- **Termination date:** 2013-11-19

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Maple Grove, MN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-127-2013

## Citation

> AI Analytics. FDA recall D-127-2013. Retrieved 2026-05-27 from https://api.ai-analytics.org/recall/D-127-2013. Source: US FDA. Licensed CC0.

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