FDA Drug recall D-127-2013
Divalproex Sodium Delayed-Release Tablets, USP, 500 mg Valproic Acid Activity, 100-count tablets per bottle, Rx only, Manufactured by Upshe…
- FDA Drug
- Class III
- terminated
- Published 2013-01-23
On 2013-01-23 the FDA classified a Class III recall of Divalproex Sodium Delayed-Release Tablets, USP, 500 mg Valproic Acid Activity, 100-count tablets per bottle, Rx only, Manufactured by Upshe… by Upsher Smith Laboratories, citing labeling: Label Error On Declared Strength; Some bottles of product were missing the color-coded strength on the primary display panel of the label.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-127-2013 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2012-12-10 |
| Published | 2013-01-23 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Upsher Smith Laboratories |
| Distribution | US |
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
Labeling: Label Error On Declared Strength; Some bottles of product were missing the color-coded strength on the primary display panel of the label.
Identifiers
| code_info | Lot #: 310162, Exp 09/14 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-127-2013%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.