Medications & Supplements/Prescription Drugs

Sabril (vigabatrin) for Oral Solution Recalled for Cross-Contamination

Agency Publication Date: August 29, 2023

Summary

Lundbeck LLC is recalling 10,543 cartons of Sabril (vigabatrin) for Oral Solution, 500 mg, due to potential cross-contamination with other drug products. Sabril is a prescription medication used to treat specific types of seizures. No incidents or injuries related to this recall have been reported to date.

Risk

The product may contain trace amounts of other drugs, which could lead to unexpected side effects or reduce the effectiveness of the seizure treatment.

What You Should Do

This recall affects Sabril (vigabatrin) for Oral Solution, 500 mg, packaged in 50-count cartons under NDC 67386-211-65.
Check your medication packaging for lot numbers 3207333A or 3207334A with an expiration date of 03/2027, or lot numbers 3214707A, 3214709A, or 3214710A with an expiration date of 02/2028.
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 additional assistance.

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: Sabril (vigabatrin) for Oral Solution (500 mg, 50 Packets)

Variants: 500 mg, Oral Solution

Lot Numbers:

3207333A (Exp 03/2027)

3207334A (Exp 03/2027)

3214707A (Exp 02/2028)

3214709A (Exp 02/2028)

3214710A (Exp 02/2028)

NDC:

67386-211-65

Quantity: 10,543 cartons

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 92894

Status: Resolved

Manufacturer: Lundbeck LLC

Sold By: Pharmacies

Manufactured In: United States

Units Affected: 10,543 cartons

Distributed To: Nationwide

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 Sabril (vigabatrin) for Oral Solution, 500 mg, packaged in 50-count cartons under NDC 67386-211-65.

Check your medication packaging for lot numbers 3207333A or 3207334A with an expiration date of 03/2027, or lot numbers 3214707A, 3214709A, or 3214710A with an expiration date of 02/2028.

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 additional assistance.