Divalproex Sodium Delayed-Release Tablets — Class III drug recall D-127-2013
Terminated recall by Upsher Smith Laboratories, Inc., reported 2013-01-23, distributed nationwide. Labeling: Label Error On Declared Strength; Some bottles of product were missing the color-coded strength on t
| Recall number | D-127-2013 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Upsher Smith Laboratories, Inc., Maple Grove, MN, United States |
| Recall initiated | 2012-12-10 |
| Classified | 2013-01-16 |
| Reported by FDA | 2013-01-23 |
| Terminated | 2013-11-19 |
| Distributed | Nationwide (US) |
| Quantity | 11,316 bottles |
| Reason classes | labeling, potency |
| NDC | 00245-0182-11 |
| Lot numbers | 09/14, 310162 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-127-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.