Medications & Supplements/Prescription Drugs

Clonazepam Orally Disintegrating Tablets Recalled for Incorrect Label Strength

Agency Publication Date: July 30, 2024

Summary

Endo Pharmaceuticals, Inc. is recalling 8,139 cartons of Clonazepam Orally Disintegrating Tablets (C-IV). Some cartons were incorrectly labeled as 0.125 mg strength when they actually contain 0.25 mg tablets. While the outer carton is wrong, the individual blister strips inside correctly identify the strength as 0.25 mg.

Risk

Patients taking this medication could accidentally consume double their intended dose, which may lead to excessive sedation, dizziness, or other side effects associated with high doses of clonazepam.

What You Should Do

This recall affects Clonazepam Orally Disintegrating Tablets, USP (C-IV) labeled as 0.125 mg strength with 60 tablets per carton (NDC 49884-306-02).
Check the labeling on your medication carton for lot number 550147301 with an expiration date of 08/31/2026. Note that while the outer box may say 0.125 mg, the blister cards inside correctly show 0.25 mg.
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 Endo Pharmaceuticals, Inc. 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 information.

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: Clonazepam Orally Disintegrating Tablets, USP (C-IV) (60 tablets)by Par Pharmaceutical

Variants: 0.125 mg (Labeled), 0.25 mg (Actual Content), Orally Disintegrating Tablet

UPC Codes:

349884306021

Lot Numbers:

550147301 (Exp. 08/31/2026)

NDC:

49884-306-02

Distributed by Par Pharmaceutical. Product was incorrectly packaged in cartons labeled 0.125 mg.

Product Images

“Correct carton label: Clonazepam Orally Disintegrating Tablets, USP 0.25 mg 60-count carton, lot 550147301, expiration date August 2026”

“Incorrect carton label: Clonazepam Orally Disintegrating Tablets, USP 0.125 mg 60-count carton, lot 550147301, expiration date August 2026”

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 94945

Status: Resolved

Manufacturer: Endo Pharmaceuticals, Inc.

Sold By: Pharmacies

Manufactured In: United States

Units Affected: 8,139 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 · FDA Press Release · 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 Clonazepam Orally Disintegrating Tablets, USP (C-IV) labeled as 0.125 mg strength with 60 tablets per carton (NDC 49884-306-02).

Check the labeling on your medication carton for lot number 550147301 with an expiration date of 08/31/2026. Note that while the outer box may say 0.125 mg, the blister cards inside correctly show 0.25 mg.

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 Endo Pharmaceuticals, Inc. 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 information.

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: Clonazepam Orally Disintegrating Tablets, USP (C-IV) (60 tablets)by Par Pharmaceutical

Variants: 0.125 mg (Labeled), 0.25 mg (Actual Content), Orally Disintegrating Tablet

UPC Codes:

349884306021

Lot Numbers:

550147301 (Exp. 08/31/2026)

NDC:

49884-306-02

Distributed by Par Pharmaceutical. Product was incorrectly packaged in cartons labeled 0.125 mg.