Divalproex Sodium Delayed-Release Tablets, USP, 500 mg, 500 Tablets bottles, Rx only, Distributed by: Bionpharma Inc., P
Summary
The FDA issued a Class II for Divalproex Sodium Delayed-Release Tablets, USP, 500 mg, 500 Tablets bottles, Rx by Bionpharma Inc.. Reason: Presence of Foreign Tablets/Capsules.
Details
Source
Drug Recall
External ID
D-0742-2026
Action Date
2026-07-29
Status
Ongoing
Category
drug
Product Description
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.
Lot/Code Info: Lot# 704C003, Exp. 12/31/2028
Quantity Affected: N/A
Reason for Recall
Presence of Foreign Tablets/Capsules
Distribution
US Nationwide.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-06-26
Company
Princeton, NJ
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 48 drug recalls issued in the same week, part of 59 drug-related FDA actions this month.
Bionpharma Inc. has 2 FDA actions in our database, including 2 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Bionpharma Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Bionpharma Inc. have FDA actions?
Bionpharma Inc. has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0742-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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