Medications & Supplements/Prescription Drugs

Dr. Reddy's Laboratories, Inc.: Divalproex Sodium Extended-release Tablets Recalled for Failed Dissolution

Agency Publication Date: February 15, 2019

Summary

Dr. Reddy's Laboratories is recalling 10,656 bottles of Divalproex Sodium Extended-release Tablets, USP 250 mg, used to treat seizure disorders and migraines. The recall was initiated because the tablets failed dissolution tests, meaning the medication may release too quickly into the body rather than over the intended period of time. This voluntary recall affects 100-count bottles distributed nationwide across the United States.

Risk

The tablets showed 'out of specification' results for high dissolution, which means the active ingredient may be released at a faster rate than designed. This could potentially lead to inconsistent drug levels in the bloodstream, affecting the medication's efficacy or increasing the risk of side effects.

What You Should Do

Check your medication bottle for Divalproex Sodium Extended-release Tablets, USP 250 mg (100-count) with NDC number 55111-533-01.
Identify if your bottle is part of the affected lot by looking for Lot number C802676 with an expiration date of 03/20.
Contact your healthcare provider or pharmacist immediately to discuss your treatment and obtain a replacement prescription before you stop taking the medication.
Return any unused tablets from the affected lot to your pharmacy for a refund and to ensure the product is properly handled.
Contact Dr. Reddy's Laboratories, Inc. at 1-888-723-3332 or via their website for further instructions regarding this recall.
For additional questions or to report adverse events, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

Full Refund

Pharmacy return and healthcare consultation

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Divalproex Sodium Extended-release Tablets, USP 250 mg (100-count bottle)

Model:

NDC 55111-533-01

Recall #: D-0507-2019

Lot Numbers:

C802676 (Exp 03/20)

Date Ranges: Expiration 03/20

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 82085

Status: Resolved

Manufacturer: Dr. Reddy's Laboratories, Inc.

Manufactured In: India, United States

Units Affected: 10,656 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 · 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.

Summary

Risk

What You Should Do

Check your medication bottle for Divalproex Sodium Extended-release Tablets, USP 250 mg (100-count) with NDC number 55111-533-01.

Identify if your bottle is part of the affected lot by looking for Lot number C802676 with an expiration date of 03/20.

Contact your healthcare provider or pharmacist immediately to discuss your treatment and obtain a replacement prescription before you stop taking the medication.

Return any unused tablets from the affected lot to your pharmacy for a refund and to ensure the product is properly handled.

Contact Dr. Reddy's Laboratories, Inc. at 1-888-723-3332 or via their website for further instructions regarding this recall.

For additional questions or to report adverse events, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.