Medications & Supplements/Prescription Drugs

MAJOR PHARMACEUTICALS: Divalproex Sodium Extended-Release Tablets Recalled for Packaging Deviation

Agency Publication Date: July 31, 2019

Summary

Major Pharmaceuticals has recalled 828 cartons of Divalproex Sodium Extended-Release Tablets (250 mg) because the medication was exposed to humidity levels exceeding 50% during the packaging process. Divalproex sodium is a prescription medication used to treat seizure disorders, certain phases of bipolar disorder, and to prevent migraine headaches. Consumers who have this medication should contact their doctor or pharmacist immediately, as the environmental exposure may have affected the drug's stability or effectiveness.

Risk

Exposure to high humidity during the packaging process can compromise the chemical stability and physical integrity of the tablets, potentially leading to a decrease in the medication's potency or a change in how the drug is released into the body.

What You Should Do

Check your medication packaging for Divalproex Sodium Extended-Release Tablets, USP 250 mg, in 100-count unit dose cartons (NDC # 0904-6363-61).
Verify the lot number and expiration date on the carton or individual unit dose blister pack; this recall specifically affects Lot # M02250 with an expiration date of 10/2020.
Contact your healthcare provider or pharmacist immediately to discuss your treatment and obtain a replacement prescription if your medication is part of the recalled lot.
Return any unused portions of the recalled medication to the pharmacy where it was purchased for a refund and to ensure proper disposal.
For further instructions or questions regarding the recall process, contact Major Pharmaceuticals at their headquarters in Livonia, Michigan.
For additional questions or to report a side effect, 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

Contact healthcare provider and return product to pharmacy.

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-unit dose carton)

Model:

NDC # 0904-6363-61

Recall #: D-1583-2019

Lot Numbers:

M02250 (EXP 10/2020)

Date Ranges: 10/2020

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 83460

Status: Resolved

Manufacturer: MAJOR PHARMACEUTICALS

Sold By: pharmacies; hospitals

Manufactured In: India, United States

Units Affected: 828 100-count unit dose cartons

Distributed To: Nationwide

Agency Last Updated: August 1, 2019

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

What You Should Do

Check your medication packaging for Divalproex Sodium Extended-Release Tablets, USP 250 mg, in 100-count unit dose cartons (NDC # 0904-6363-61).

Verify the lot number and expiration date on the carton or individual unit dose blister pack; this recall specifically affects Lot # M02250 with an expiration date of 10/2020.

Contact your healthcare provider or pharmacist immediately to discuss your treatment and obtain a replacement prescription if your medication is part of the recalled lot.

Return any unused portions of the recalled medication to the pharmacy where it was purchased for a refund and to ensure proper disposal.

For further instructions or questions regarding the recall process, contact Major Pharmaceuticals at their headquarters in Livonia, Michigan.

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