CLASS II ONGOING Drug recall · Reported 29 Jul 2026 · FDA Enforcement Report
Divalproex Sodium Delayed-Release Tablets, USP, 500 mg recalled
Bionpharma is recalling Divalproex Sodium Delayed-Release Tablets, USP, 500 mg, distributed nationwide in the US. The recall was initiated on 26 Jun 2026 and the FDA has classified it as Class II.
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-0742-2026
- FDA event ID
- 99316
- Recalling firm
- Bionpharma, Princeton, NJ
- Brand
- Divalproex Sodium
- Manufacturer
- Bionpharma Inc.
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 26 Jun 2026
- FDA classified
- 6 Aug 2026
- Reported
- 29 Jul 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Seizure Medication
Timeline
| 26 Jun 2026 | Recall initiated by company | |
| 29 Jul 2026 | Published in enforcement report | +33 days |
| 6 Aug 2026 | Classified by FDA | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Presence of Foreign Tablets/Capsules
Product as listed by the FDA
Divalproex Sodium Delayed-Release Tablets, USP, 500 mg, 500 Tablets bottles, Rx only, Distributed by: Bionpharma Inc., Princeton, NJ 08540, Made in India, NDC 69452-435-30.
Where it was distributed
US Nationwide.
Questions about this recall
Is Divalproex Sodium Delayed-Release Tablets, USP, 500 mg recalled?
Yes. Bionpharma recalled Divalproex Sodium Delayed-Release Tablets, USP, 500 mg on 26 Jun 2026. The recall is Class II and its status is Ongoing. Recall number D-0742-2026.
Why was it recalled?
Presence of Foreign Tablets/Capsules
Which lots are affected?
Lot# 704C003, Exp. 12/31/2028
Where was it sold?
US Nationwide.
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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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| Drug | CLASS III | Doxylamine Succinate and Pyridoxine HCl Delayed-Release recalledDoxylamine Succinate And Pyridoxine Hydrochloride | Bionpharma | Other | Nationwide |
| Drug | CLASS I | Atovaquone Oral Suspension, USP 750 mg recalled by BionpharmaAtovaquone | Bionpharma | Sterility | Nationwide |
| Drug | CLASS II | Clobazam Oral Suspension, 5 mg/mL recalled by BionpharmaClobazam | Bionpharma | Sterility | Nationwide |
Other Divalproex recalls
All 16| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| 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 |
| Drug | CLASS II | Divalproex Sodium Extended-Release Tablets, USP, 250 mg a) bottle recalled | Dr. Reddy's Laboratories | Manufacturing (CGMP) Deviations | Nationwide |