Divalproex Sodium Delayed-Release Tablets recall
FDA recall D-0742-2026 · initiated Jun 26, 2026
Bionpharma Inc. recalled Divalproex Sodium Delayed-Release Tablets in Jun 2026 — an FDA Class II recall (D-0742-2026) because Presence of Foreign Tablets/Capsules.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Presence of Foreign Tablets/Capsules
Something got into the product
A physical or chemical contaminant was found — glass or metal fragments, or a solvent that should not be there.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: N/A
Details
- Product
- 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.
- Recalling company
- Bionpharma Inc
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- US Nationwide.
- Initiated
- Jun 26, 2026
- FDA report date
- Jul 29, 2026
Frequently asked
- Was Divalproex Sodium Delayed-Release Tablets recalled?
- Bionpharma Inc. recalled Divalproex Sodium Delayed-Release Tablets in Jun 2026 — an FDA Class II recall (D-0742-2026) because Presence of Foreign Tablets/Capsules. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Divalproex Sodium Delayed-Release Tablets recalled?
- Per the FDA enforcement record, the reason for recall D-0742-2026 was: Presence of Foreign Tablets/Capsules
- Is a recalled Divalproex Sodium Delayed-Release Tablets dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Divalproex Sodium Delayed-Release Tablets are affected?
- Distributed: US Nationwide.. The recall covers these lots — Lot# 704C003, Exp. 12/31/2028. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0742-2026.