Medications & Supplements/Prescription Drugs

Clobazam Tablets Recalled for Presence of Foreign Tablets or Capsules

Agency Publication Date: January 14, 2025

Summary

Amerisource Health Services LLC is recalling 4,640 units of Clobazam Tablets (10 mg), manufactured by Amneal Pharmaceuticals and distributed by American Health Packaging. The recall was initiated because tablets or capsules of a different medication were found inside the Clobazam packaging. Clobazam is a prescription medication used to treat seizures, and the presence of a foreign drug could lead to unintended side effects or failure to control seizures.

Risk

Taking the wrong medication can lead to serious adverse health effects or cause a patient's underlying condition to go untreated. No specific injuries or adverse events have been reported in the data, but the presence of foreign medication in a blister pack represents a significant safety failure.

What You Should Do

This recall affects Clobazam Tablets (10 mg) packaged in 30-count cartons (containing three 10-count blister cards) with NDC 60687-423-11. The affected product is identified by Lot 1018598 with an expiration date of 10/31/2025.
If you have health concerns or believe you have taken the wrong medication, contact your healthcare provider or pharmacist immediately. 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 Tablets, 10 mg (30-count carton)

Variants: 10 mg, Tablet, 30 tablets per carton (3x10 blister cards)

Lot Numbers:

1018598 (Exp. Date 10/31/2025)

NDC:

60687-423-11

Rx Only; Manufactured by Amneal Pharmaceuticals LLC; Distributed by American Health Packaging.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 96117

Status: Active

Manufacturer: Amerisource Health Services LLC

Sold By: Pharmacies

Manufactured In: United States

Units Affected: 4640 units

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 Clobazam Tablets (10 mg) packaged in 30-count cartons (containing three 10-count blister cards) with NDC 60687-423-11. The affected product is identified by Lot 1018598 with an expiration date of 10/31/2025.

If you have health concerns or believe you have taken the wrong medication, contact your healthcare provider or pharmacist immediately. 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.