Zydus Divalproex Tablets Recall: Failed Dissolution Risk
Zydus Pharmaceuticals recalls 500mg Divalproex Sodium Delayed Release Tablets due to failed dissolution specifications and stability issues. Affected products include specific NDC numbers and expiration dates.
Recall notice
Failed Dissolution Specifications; 9 month long term stability
Contact the company
What happened, in plain English
Zydus Pharmaceuticals is recalling 500mg Divalproex Sodium Delayed Release Tablets that may not dissolve properly and could be unstable over time. This recall affects specific product batches with certain expiration dates and NDC numbers. Read more at govinfonow.com/recall/41812-zydus-divalproex-tablets-recall-failed-dissolution-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/41812-zydus-divalproex-tablets-recall-failed-dissolution-risk · Updated October 8, 2026 · FDA enforcement record: FDA #D-0617-2017
Cite this page
“Zydus Divalproex Tablets Recall: Failed Dissolution Risk.” GovInfoNow, updated October 8, 2026. https://govinfonow.com/recall/41812-zydus-divalproex-tablets-recall-failed-dissolution-risk. Based on FDA recall #D-0617-2017 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0617-2017%22&limit=1).
Why it’s dangerous
The tablets may not dissolve properly as intended, which could lead to inconsistent medication delivery. Additionally, the long-term stability of these tablets is compromised, potentially causing degradation over time.
Who’s affected
People who have the specific 500mg Divalproex Sodium Delayed Release Tablets with NDC numbers 68382-033-01 or 68382-033-05 are affected. Those using these medications for seizure disorders or mood conditions are most at risk.
How to tell if you have this one
Check for the product name 'Divalproex Sodium Delayed Release Tablets, USP, 500 mg' with NDC numbers 68382-033-01 (100 count) or 68382-033-05 (500 count). The expiration dates listed in the recall are specific to each batch.
- Brand
Zydus Pharmaceuticals- Category
Drug
What to do — step by step
Check Product Details
Look for the NDC numbers 68382-033-01 or 68382-033-05 on the bottle label to confirm if your tablets are affected.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 3.5 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Other Zydus Pharmaceuticals recalls
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0617-2017 (March 15, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0617-2017 to see it in context.
- Plain-language summary written by qwen3:4b on October 8, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.