Medications & Supplements/Prescription Drugs

Divalproex Sodium Extended-Release Tablets Recalled for Dissolution Failure

Agency Publication Date: March 27, 2024

Summary

Amneal Pharmaceuticals of New York, LLC has recalled 21,452 bottles of Divalproex Sodium Extended-release Tablets (250 mg) because they failed dissolution testing. These prescription tablets, used to treat various conditions including seizures and migraine prevention, may not release the medication into the body at the correct rate. The recall affects 100-count bottles distributed nationwide to pharmacies and healthcare providers.

Risk

The tablets failed dissolution specifications, meaning the medication may not be absorbed by the patient as intended, potentially reducing the drug's effectiveness. No injuries or adverse incidents have been reported in connection with this recall.

What You Should Do

The recalled products are 100-count bottles of Divalproex Sodium Extended-release Tablets, USP 250 mg, identified by NDC 65162-755-10.
Identify if your medication is affected by checking the lot number and expiration date on the bottle label. Affected lots include AR210704, AR210706, AR210707, AR210708, and AR210709, all with an expiration date of 04/2024.
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 Amneal Pharmaceuticals of New York, LLC for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions regarding this recall.

Your Remedy Options

You have 2 options:

Option 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

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 Extended-release Tablets, USP 250 mg (100-count bottle)

Variants: 250 mg, Extended-release, Tablet

Lot Numbers:

AR210704 (Exp 04/2024)

AR210706 (Exp 04/2024)

AR210707 (Exp 04/2024)

AR210708 (Exp 04/2024)

AR210709 (Exp 04/2024)

NDC:

65162-755-10

Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Ahmedabad, INDIA; Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 93976

Status: Resolved

Manufacturer: Amneal Pharmaceuticals of New York, LLC

Sold By: pharmacies; healthcare providers

Manufactured In: India, United States

Units Affected: 21,452/100 count 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

What You Should Do

The recalled products are 100-count bottles of Divalproex Sodium Extended-release Tablets, USP 250 mg, identified by NDC 65162-755-10.

Identify if your medication is affected by checking the lot number and expiration date on the bottle label. Affected lots include AR210704, AR210706, AR210707, AR210708, and AR210709, all with an expiration date of 04/2024.

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 Amneal Pharmaceuticals of New York, LLC for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions regarding this recall.

Your Remedy Options

You have 2 options:

Option 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

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 Extended-release Tablets, USP 250 mg (100-count bottle)

Variants: 250 mg, Extended-release, Tablet

Lot Numbers:

AR210704 (Exp 04/2024)

AR210706 (Exp 04/2024)

AR210707 (Exp 04/2024)

AR210708 (Exp 04/2024)

AR210709 (Exp 04/2024)

NDC:

65162-755-10

Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Ahmedabad, INDIA; Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807