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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Critical RiskFDA Drug
Medications & Supplements/Prescription Drugs

PAR Pharmaceutical Clonazepam Orally Disintegrating Tablets Recalled for Labeling Error

Agency Publication Date: January 3, 2025
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Summary

Endo USA, Inc. is recalling approximately 113,331 cartons of PAR Pharmaceutical Clonazepam Orally Disintegrating Tablets, USP (0.125 mg, 0.25 mg, 1 mg, and 2 mg strengths). Some cartons were incorrectly labeled with the wrong medication strength on the outside packaging, although the individual blister strips inside the carton reflect the correct strength. This error could lead patients to take a different dose than prescribed by their healthcare provider.

Risk

A labeling error on the carton could result in a patient taking more or less medication than intended. This may lead to serious health consequences, such as respiratory depression, excessive sedation, or withdrawal symptoms if the dose is significantly lower than required.

What You Should Do

  1. This recall affects Clonazepam Orally Disintegrating Tablets, USP (0.125 mg, 0.25 mg, 1 mg, and 2 mg strengths) distributed by PAR Pharmaceutical in cartons of 60 tablets.
  2. Check your medication carton for the following NDC numbers: 49884-306-02, 49884-307-02, 49884-309-02, or 49884-310-02. You must also check the lot number printed on the side of the carton. See the Affected Products section below for the full list of affected codes.
  3. If you have health concerns about your medication or the dosage you have taken, contact your healthcare provider or pharmacist immediately.
  4. Return any unused product to the place of purchase for a refund, throw it away, or contact Endo USA, Inc. at 1-888-723-3332 for further instructions on how to handle the recalled items.
  5. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) 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: Clonazepam Orally Disintegrating Tablet, USP (60 Tablets per carton)
Variants: 2 mg, C-IV, Rx Only
Serial Numbers:
221435249307
Lot Numbers:
550176501 (Exp 02/28/2027)
550176601 (Exp 02/28/2027)
NDC:
49884-310-02
49884-310-52
GTIN:
00349884310028

Distributed by PAR Pharmaceutical; 10 blister cards containing 6 tablets each per carton.

Product: Clonazepam Orally Disintegrating Tablets, USP (60 tablets per carton)
Variants: 0.125 mg, C-IV, Rx Only
Lot Numbers:
550174101 (Exp 01/31/2027)
NDC:
49884-306-02
49884-306-52

Distributed by PAR Pharmaceutical; 10 blister cards containing 6 tablets each per carton.

Product: Clonazepam Orally Disintegrating Tablets, USP (60 tablets per carton)
Variants: 0.25 mg, C-IV, Rx Only
Lot Numbers:
550142801 (Exp 08/31/2026)
550142901 (Exp 08/31/2026)
550143001 (Exp 08/31/2026)
550143101 (Exp 08/31/2026)
550143201 (Exp 08/31/2026)
550143301 (Exp 08/31/2026)
550143401 (Exp 08/31/2026)
550147201 (Exp 08/31/2026)
550147401 (Exp 08/31/2026)
NDC:
49884-307-02
49884-307-52

Distributed by PAR Pharmaceutical; 10 blister cards containing 6 tablets each per carton.

Product: Clonazepam Orally Disintegrating Tablets, USP (60 tablets per carton)
Variants: 1 mg, C-IV, Rx Only
Lot Numbers:
550145201 (Exp 08/31/2026)
550175901 (Exp 02/28/2027)
550176001 (Exp 02/28/2027)
550176201 (Exp 02/28/2027)
NDC:
49884-309-02
49884-309-52

Distributed by PAR Pharmaceutical; 10 blister cards containing 6 tablets each per carton.

Product Images

“PAR Pharmaceutical Clonazepam Orally Disintegrating Tablets, USP, 1 mg, 60 Tablets”

“PAR Pharmaceutical Clonazepam Orally Disintegrating Tablets, USP, 1 mg, 60 Tablets”

“Carton side label, shows Lot 550176501, EXP 2027-02”

“Carton side label, shows Lot 550176501, EXP 2027-02”

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95778
Status: Active
Manufacturer: Endo USA, Inc.
Sold By: Pharmacies
Manufactured In: United States
Units Affected: 4 products (9,816 cartons; 8,029 cartons; 72,973 cartons; 22,513 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.