Class II · ModerateRecall completed
Divalproex Sodium
Could cause temporary or reversible harm; serious harm is unlikely.
Does this affect you?
Check your lot numberLot # AR210704, exp. date 04/2024 AR210706, exp. date 04/2024 AR210707, exp. date 04/2024 AR210708, exp. date 04/2024 AR210709, exp. date 04/2024
Where it was soldProduct was distributed nationwide.
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.
What happened
Failed dissolution specifications
What to do
- Check the lot number and expiry on your medicine against the recall above.
- Talk to your pharmacist or doctor before changing anything — don't stop on your own.
- Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).
Who makes it
Made byAmneal Pharmaceuticals Pvt. Ltd. Ahmedabad, INDIA, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807 foreign manufacturer
| Brand name | DIVALPROEX SODIUM |
| Generic name | DIVALPROEX SODIUM |
| Active ingredient(s) | DIVALPROEX SODIUM |
| Distributed by / for | Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807 |
| NDC | 65162-755-10 |
Show the full FDA record
| Full product label | Divalproex Sodium Extended-release Tablets, USP 250 mg, Rx Only, 100 tablets, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Ahmedabad, INDIA, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807, NDC 65162-755-10. NDC# 65162-755-10 |
| Recalling firm | Amneal Pharmaceuticals of New York, LLC |
| Distribution | Product was distributed nationwide. |
| Quantity | 21,452/100 count bottles |
| Recall initiated | 2023-12-26 |
| Report date | 2024-04-03 |
| Recall completed | 2024-08-16 |
| Recall number | D-0426-2024 |
| Classification | Class II |
| FDA status | Terminated |
| Origin on file | Brookhaven NY United States |
Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗
This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.