CLASS III Drug recall · Reported 23 Jan 2013 · FDA Enforcement Report
Divalproex Sodium Delayed-Release Tablets recalled
Upsher Smith Laboratories is recalling Divalproex Sodium Delayed-Release Tablets, USP, 500 mg Valproic Acid Activity tablets per, distributed nationwide in the US. The recall was initiated on 10 Dec 2012 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-127-2013
- FDA event ID
- 64085
- Recalling firm
- Upsher Smith Laboratories, Maple Grove, MN
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 10 Dec 2012
- FDA classified
- 16 Jan 2013
- Reported
- 23 Jan 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Other Reasons
- Drug class
- Seizure Medication
Timeline
| 10 Dec 2012 | Recall initiated by company | |
| 16 Jan 2013 | Classified by FDA | +37 days |
| 23 Jan 2013 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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.
Where it was distributed
Nationwide and Puerto Rico
Questions about this recall
Why was it 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.
Which lots are affected?
Lot #: 310162, Exp 09/14
Where was it sold?
Nationwide and Puerto Rico
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Upsher Smith Laboratories
All 6| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Bexarotene Capsules, 75 mg recalled by Upsher Smith LaboratoriesBexarotene | Upsher Smith Laboratories | Potency & Assay | 4 states |
| Drug | CLASS II | Bumetanide Tablets, USP, 1 mg recalled by Upsher Smith Laboratories | Upsher Smith Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS II | Bumetanide Tablets, USP, 2 mg recalled by Upsher Smith Laboratories | Upsher Smith Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS III | Oxandrolone Tablets, USP, 10 mg recalled by Upsher Smith Laboratories | Upsher Smith Laboratories | Labeling Errors | Nationwide |
| Drug | CLASS II | Propranolol Hydrochloride Extended-release Capsules, USP, 80 mg recalled | Upsher Smith Laboratories | Potency & Assay | FL, NJ |
Other Divalproex recalls
All 16| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Divalproex Sodium Delayed-Release Tablets, USP, 500 mg recalledDivalproex Sodium | Bionpharma | Other | Nationwide |
| Drug | CLASS II | Divalproex Sodium Extended-release Tablets, USP 250 mg recalledDivalproex Sodium | Amneal Pharmaceuticals of New York | Potency & Assay | Nationwide |
| Drug | CLASS II | Divalproex Sodium Extended Release Tablets, USP, 250 mg recalledDivalproex Sodium | Amneal Pharmaceuticals of New York | Potency & Assay | Nationwide |
| Drug | CLASS II | Divalproex Sodium Delayed-Release Tablets, USP 500mg recalledDivalproex Sodium | SUN Pharmaceutical Industries | Potency & Assay | Nationwide |
| Drug | CLASS II | Divalproex Sodium Extended-release Tablets, USP Tablets recalledDivalproex Sodium | Major Pharmaceuticals | Manufacturing (CGMP) Deviations | Nationwide |