Medications & Supplements/Prescription Drugs

Tiagabine Hydrochloride Tablets Recalled for Failed Impurity Testing

Agency Publication Date: July 11, 2023

Summary

SUN PHARMACEUTICAL INDUSTRIES INC is recalling 8,880 bottles of Tiagabine Hydrochloride tablets (2 mg) used for treating seizures. The recall was issued because the tablets failed testing for impurities, meaning the medication contains levels of substances that fall outside of the safety and quality specifications. No incidents or injuries have been reported to date in connection with this recall.

Risk

The presence of impurities above the approved limits can lead to unexpected side effects or may change how the medication works in the body. While no injuries are reported, using medication that does not meet impurity standards poses a potential health risk.

What You Should Do

The recalled product is Tiagabine Hydrochloride Tablets, 2 mg, sold in 30-count bottles with NDC 62756-200-83.
Identify affected products by looking for lot number HAC3339A with an expiration date of 07/2023 printed on the bottle label.
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 the manufacturer for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for more information 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: Tiagabine Hydrochloride Tablets (30-count bottle)

Variants: 2 mg

Lot Numbers:

HAC3339A (Exp 07/2023)

NDC:

62756-200-83

Recall #: D-0914-2023

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 92671

Status: Resolved

Manufacturer: SUN PHARMACEUTICAL INDUSTRIES INC

Sold By: Pharmacies

Manufactured In: United States, India

Units Affected: 8,880 30-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 product is Tiagabine Hydrochloride Tablets, 2 mg, sold in 30-count bottles with NDC 62756-200-83.

Identify affected products by looking for lot number HAC3339A with an expiration date of 07/2023 printed on the bottle label.

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 the manufacturer for further instructions.

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