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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

Divalproex Sodium Delayed-Release Tablets Recalled for Dissolution Failure

Agency Publication Date: July 26, 2022
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Summary

Sun Pharmaceutical Industries Inc. has voluntarily recalled 9,552 bottles of Divalproex Sodium (valproate) Delayed-Release Tablets, USP 500mg. This medication, primarily used to treat seizures and bipolar disorder, was found to fail dissolution testing during routine stability checks. No incidents or injuries have been reported to date, and the product was distributed to pharmacies nationwide.

Risk

The tablets may not dissolve correctly in the digestive system, which can prevent the medication from being absorbed at the proper rate. This failure could lead to the medication being less effective at controlling symptoms or causing unexpected side effects.

What You Should Do

  1. This recall affects 100-count bottles of Divalproex Sodium Delayed-Release Tablets, USP 500mg, with NDC 62756-798-88 and Lot HAC1312A (Expiration Date 05/2024).
  2. If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact Sun Pharmaceutical Industries Inc. for further instructions.
  3. Call the FDA Consumer Complaint hotline at 1-888-723-3332 for additional questions regarding this recall.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 1: Full Refund
How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund
๐Ÿ—‘๏ธOption 2: Dispose of Product
How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Divalproex Sodium Delayed-Release Tablets (500mg, 100 Tablets)
Variants: Delayed-Release, 500mg, Tablets
Lot Numbers:
HAC1312A (Exp. 05/2024)
NDC:
62756-798-88

Distributed by Sun Pharmaceutical Industries, Inc., Cranbury, NJ; Manufactured by Sun Pharmaceutical Industries, Ltd., Gujarat, India.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 90495
Status: Resolved
Manufacturer: SUN PHARMACEUTICAL INDUSTRIES INC
Sold By: Pharmacies nationwide
Manufactured In: India, United States
Units Affected: 9552 bottles
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.