Medications & Supplements/Prescription Drugs

Glenmark Zonisamide Capsules Recalled for Manufacturing Deviations

Agency Publication Date: April 27, 2022

Summary

Glenmark Pharmaceuticals Inc., USA is voluntarily recalling 30,183 bottles of Zonisamide (the generic name for Zonegran), a prescription medication used to treat seizures in adults with epilepsy. The recall was initiated because of manufacturing deviations that violated quality standards. This recall includes specific lots of 25 mg, 50 mg, and 100 mg capsules sold in 100-count and 500-count bottles.

Risk

The products were manufactured under conditions that did not follow current Good Manufacturing Practice (cGMP) standards. While no injuries or health problems have been reported to date, deviations in manufacturing can affect the quality and consistency of the medication.

What You Should Do

This recall affects Zonisamide Capsules (25 mg, 50 mg, and 100 mg strengths) sold in 100-count or 500-count white plastic bottles under the Glenmark Pharmaceuticals brand.
Check your prescription bottle label for the following identifying codes: NDC 68462-128-01 (Lot 29200052, Exp 4/30/2023), NDC 68462-129-01 (Lot 29200064, Exp 5/31/2023), NDC 68462-130-01 (Lot 29200053, Exp 4/30/2023), or NDC 68462-130-05 (Lot 29200054, Exp 4/30/2023).
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 Glenmark Pharmaceuticals Inc., USA for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

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: Zonisamide Capsules USP (25 mg)

Variants: 25 mg, 100-count bottle

Lot Numbers:

29200052 (Exp 4/30/2023)

NDC:

68462-128-01

Recall #: D-0791-2022; Quantity: 11,136 bottles

Product: Zonisamide Capsules USP (50 mg)

Variants: 50 mg, 100-count bottle

Lot Numbers:

29200064 (Exp 5/31/2023)

NDC:

68462-129-01

Recall #: D-0792-2022; Quantity: 12,003 bottles

Product: Zonisamide Capsules USP (100 mg)

Variants: 100 mg, 100-count bottle, 500-count bottle

Lot Numbers:

29200053 (Exp 4/30/2023)

29200054 (Exp 4/30/2023)

NDC:

68462-130-01

68462-130-05

Recall #: D-0793-2022; Quantity: a) 7,044 bottles; b) 1,014 bottles

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 90029

Status: Resolved

Manufacturer: Glenmark Pharmaceuticals Inc., USA

Sold By: Pharmacies nationwide

Manufactured In: United States

Units Affected: 3 products (11,136 bottles; 12,003 bottles; a) 7,044 bottles; b) 1,014 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

This recall affects Zonisamide Capsules (25 mg, 50 mg, and 100 mg strengths) sold in 100-count or 500-count white plastic bottles under the Glenmark Pharmaceuticals brand.

Check your prescription bottle label for the following identifying codes: NDC 68462-128-01 (Lot 29200052, Exp 4/30/2023), NDC 68462-129-01 (Lot 29200064, Exp 5/31/2023), NDC 68462-130-01 (Lot 29200053, Exp 4/30/2023), or NDC 68462-130-05 (Lot 29200054, Exp 4/30/2023).

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 Glenmark Pharmaceuticals Inc., USA for further instructions.

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

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: Zonisamide Capsules USP (25 mg)

Variants: 25 mg, 100-count bottle

Lot Numbers:

29200052 (Exp 4/30/2023)

NDC:

68462-128-01

Recall #: D-0791-2022; Quantity: 11,136 bottles

Product: Zonisamide Capsules USP (50 mg)

Variants: 50 mg, 100-count bottle

Lot Numbers:

29200064 (Exp 5/31/2023)

NDC:

68462-129-01

Recall #: D-0792-2022; Quantity: 12,003 bottles

Product: Zonisamide Capsules USP (100 mg)

Variants: 100 mg, 100-count bottle, 500-count bottle

Lot Numbers:

29200053 (Exp 4/30/2023)

29200054 (Exp 4/30/2023)

NDC:

68462-130-01

68462-130-05

Recall #: D-0793-2022; Quantity: a) 7,044 bottles; b) 1,014 bottles

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 90029

Status: Resolved

Manufacturer: Glenmark Pharmaceuticals Inc., USA

Sold By: Pharmacies nationwide

Manufactured In: United States

Units Affected: 3 products (11,136 bottles; 12,003 bottles; a) 7,044 bottles; b) 1,014 bottles)

Distributed To: Nationwide