Medications & Supplements/Prescription Drugs

Amneal Clobazam Tablets Recalled for Presence of Foreign Tablets or Capsules

Agency Publication Date: January 6, 2025

Summary

Amerisource Health Services LLC is recalling 5,178 cartons of Clobazam (10 mg), a prescription anti-seizure medication, because foreign tablets or capsules from a different product were found inside the packaging. The medication was manufactured by Amneal Pharmaceuticals and distributed by American Health Packaging in cartons containing three 10-count blister cards. Consumers who find a tablet or capsule that does not match the appearance of their prescribed medication should not ingest it.

Risk

Ingesting a foreign medication instead of the prescribed Clobazam could lead to serious adverse drug reactions or a loss of seizure control. While no specific injuries have been reported, the presence of unidentified medications in a prescription blister pack poses a significant health risk.

What You Should Do

This recall involves Clobazam Tablets, 10 mg, packaged in 30-count cartons (three 10-count blister cards) with NDC 60687-423-21. The only affected product is Lot 1019594 with an expiration date of 12/31/2025.
If you have health concerns or believe you may have ingested 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 Amerisource Health Services LLC for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for additional questions 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: Clobazam Tablets, 10 mg (30-count carton)by Amneal Pharmaceuticals LLC

Variants: 10 mg, Tablet

Lot Numbers:

1019594 (Exp. 12/31/2025)

NDC:

60687-423-21

Packaged in 3x10 blister cards per carton; Rx Only; Manufactured by Amneal Pharmaceuticals LLC; Distributed by American Health Packaging.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 96017

Status: Active

Manufacturer: Amerisource Health Services LLC

Sold By: Pharmacies

Manufactured In: United States

Units Affected: 5,178 cartons

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 involves Clobazam Tablets, 10 mg, packaged in 30-count cartons (three 10-count blister cards) with NDC 60687-423-21. The only affected product is Lot 1019594 with an expiration date of 12/31/2025.

If you have health concerns or believe you may have ingested 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 Amerisource Health Services LLC for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for additional questions regarding this recall.