FDA recall, , Moderate risk
Bionpharma Divalproex Sodium Delayed-Release Tablets
Divalproex Sodium Delayed-Release Tablets may contain foreign tablets or capsules.
Summary by Recall Canary from the FDA notice
What happened
Bionpharma Inc., of Princeton, New Jersey, began a recall of Divalproex Sodium Delayed-Release Tablets, USP, 500 mg, 500 Tablets bottles, Rx only, distributed by Bionpharma Inc., Princeton, NJ 08540, Made in India, due to the presence of foreign tablets or capsules. The recall began June 26, 2026, and was added to the FDA's Enforcement Report on July 17, 2026, with distribution nationwide in the US.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medicine recalls:
- Check the FDA or company notice for instructions specific to this product.
- Ask your pharmacist or doctor whether your lot is affected and what to do.
Is yours affected?
Match the NDC and lot code listed under your product.
An NDC (National Drug Code) is usually printed on the drug's label.
- NDC
- 69452-435-30
- Lot code
- 704C003
Recall details
- Company began the recall
- Sold in
US Nationwide.
- Company
- Bionpharma Inc.Princeton, New Jersey
- Hazard
- Foreign object
- Risk
Moderate risk
Taking it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 99316
- Recall number
- D-0742-2026
All recalls from Bionpharma Inc.
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report
Listed on Recall Canary
In FDA's weekly enforcement report
Classified by FDA
Summary updated
