Sun Pharma Recalls Divalproex Sodium 500mg Due to Dissolution Failure
Sun Pharmaceutical recalls 9,552 bottles of Divalproex Sodium Delayed-Release Tablets 500mg due to failed dissolution specifications. Check your lot number.
Use caution until it’s fixed
Failed Dissolution Specifications: Failure occurred during routine stability testing of dissolution test.
Contact the company
What happened, in plain English
Sun Pharmaceutical Industries Inc. is recalling one lot of Divalproex Sodium Delayed-Release Tablets, USP 500mg because the medication may not dissolve properly in the body. This failure was identified during routine stability testing. The recall affects 9,552 bottles distributed nationwide in the USA. Read more at govinfonow.com/recall/34505-sun-pharma-recalls-divalproex-sodium-500mg-due-to-dissolution-failure.
Source Summary by GovInfoNow · govinfonow.com/recall/34505-sun-pharma-recalls-divalproex-sodium-500mg-due-to-dissolution-failure · Updated October 10, 2026 · FDA enforcement record: FDA #D-1291-2022
Cite this page
“Sun Pharma Recalls Divalproex Sodium 500mg Due to Dissolution Failure.” GovInfoNow, updated October 10, 2026. https://govinfonow.com/recall/34505-sun-pharma-recalls-divalproex-sodium-500mg-due-to-dissolution-failure. Based on FDA recall #D-1291-2022 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1291-2022%22&limit=1).
Why it’s dangerous
The tablets failed dissolution specifications, meaning they might not release the drug at the intended rate or location in the digestive tract. This could result in the medication not working as expected to treat the condition it was prescribed for.
Who’s affected
Patients currently taking Divalproex Sodium Delayed-Release Tablets prescribed by a healthcare provider. Individuals who purchased this specific lot from pharmacies across the United States are affected.
How to tell if you have this one
Look for bottles of Divalproex Sodium Delayed-Release Tablets, USP 500mg, Rx Only, containing 100 tablets. The National Drug Code (NDC) is 62756-798-88. The specific lot number is HAC1312A with an expiration date of 05/2024.
- Brand
Sun Pharmaceutical- Category
Drug
What to do — step by step
Check Your Medication
Verify if your bottle matches the NDC 62756-798-88 and lot number HAC1312A with an expiration date of 05/2024.
Contact Your Pharmacist
If you have the recalled product, contact your pharmacist or healthcare provider immediately for instructions on replacement or disposal.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide in the USA” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 11 months 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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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-1291-2022 (June 27, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1291-2022 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 10, 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.