Medications & Supplements/Prescription Drugs

VistaPharm Clobazam Oral Suspension Recalled for Stability Failure

Agency Publication Date: January 18, 2022

Summary

VistaPharm, Inc. is recalling 18,456 bottles of Clobazam Oral Suspension (2.5 mg/mL), a prescription medication used to treat seizures. This recall was issued because the product failed stability specifications, meaning the drug's quality or potency may not be maintained through its expiration date. No incidents or injuries have been reported to date.

Risk

If the medication fails to maintain its stability, it may not work effectively to control seizures as intended. This could potentially lead to a recurrence of seizures in patients who rely on the medication for treatment.

What You Should Do

This recall affects 120 mL bottles of Clobazam Oral Suspension 2.5 mg/mL (NDC 66689-058-04) manufactured by VistaPharm, Inc.
Check the lot number and expiration date printed on the bottle label to see if your product is included in this recall. See the Affected Products section below for the full list of affected codes.
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 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: Clobazam Oral Suspension 2.5 mg/mL (120 mL)

Variants: 2.5 mg/mL, 120 mL bottles, Rx only

Lot Numbers:

678900 (Exp. 5/31/2022)

682000 (Exp. 5/31/2022)

682400 (Exp. 5/31/2022)

680600 (Exp. 5/30/2022)

680800 (Exp. 5/30/2022)

681000 (Exp. 5/30/2022)

683200 (Exp. 6/30/2022)

685200 (Exp. 6/30/2022)

728900 (Exp. 12/31/2022)

733100 (Exp. 12/31/2022)

738600 (Exp. 1/31/2023)

740600 (Exp. 2/28/2023)

741600 (Exp. 2/28/2023)

749800 (Exp. 3/31/2023)

750900 (Exp. 3/31/2023)

752400 (Exp. 3/31/2023)

775700 (Exp. 6/30/2023)

NDC:

66689-058-04

Recall #: D-0376-2022

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 89395

Status: Resolved

Manufacturer: VistaPharm, Inc.

Sold By: Pharmacies nationwide

Manufactured In: United States

Units Affected: 18,456 bottles

Distributed To: Nationwide

Agency Last Updated: January 26, 2022

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 120 mL bottles of Clobazam Oral Suspension 2.5 mg/mL (NDC 66689-058-04) manufactured by VistaPharm, Inc.

Check the lot number and expiration date printed on the bottle label to see if your product is included in this recall. See the Affected Products section below for the full list of affected codes.

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 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: Clobazam Oral Suspension 2.5 mg/mL (120 mL)

Variants: 2.5 mg/mL, 120 mL bottles, Rx only

Lot Numbers:

678900 (Exp. 5/31/2022)

682000 (Exp. 5/31/2022)

682400 (Exp. 5/31/2022)

680600 (Exp. 5/30/2022)

680800 (Exp. 5/30/2022)

681000 (Exp. 5/30/2022)

683200 (Exp. 6/30/2022)

685200 (Exp. 6/30/2022)

728900 (Exp. 12/31/2022)

733100 (Exp. 12/31/2022)

738600 (Exp. 1/31/2023)

740600 (Exp. 2/28/2023)

741600 (Exp. 2/28/2023)

749800 (Exp. 3/31/2023)

750900 (Exp. 3/31/2023)

752400 (Exp. 3/31/2023)

775700 (Exp. 6/30/2023)

NDC:

66689-058-04

Recall #: D-0376-2022