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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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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

Clonazepam Orally Disintegrating Tablets Recalled for Oversized Tablets

Agency Publication Date: June 22, 2022
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Summary

Sun Pharmaceutical Industries Inc. has voluntarily recalled 4,608 bottles of Clonazepam Orally Disintegrating Tablets, USP (0.125 mg). The recall was initiated because an oversized tablet was discovered in a bottle. This prescription medication is used to treat seizures and panic disorders. No injuries or incidents have been reported in connection with this issue.

Risk

An oversized tablet may contain a higher dosage of medication than intended. Ingesting a higher dose than prescribed can lead to unintentional side effects or medical complications associated with clonazepam.

What You Should Do

  1. This recall involves 60-count bottles of Clonazepam Orally Disintegrating Tablets, USP (0.125 mg) with NDC 57664-783-68, Lot MHC1430A, and an expiration date of 09/2023.
  2. 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.
  3. For more information, call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA).

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 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
๐Ÿ—‘๏ธ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 (60 Tablets)
Variants: 0.125 mg, Rx Only, Orally Disintegrating Tablets
Lot Numbers:
MHC1430A (Exp 09/2023)
NDC:
57664-783-68

Manufactured by Sun Pharmaceutical Industries Ltd. Mumbai, India; Distributed by Sun Pharmaceutical Industries Inc., Cranbury, NJ.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 90340
Status: Resolved
Manufacturer: SUN PHARMACEUTICAL INDUSTRIES INC
Sold By: pharmacies
Manufactured In: India, United States
Units Affected: 4608 bottles
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 ยท 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.