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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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Low RiskFDA Drug
Medications & Supplements/Prescription Drugs

Genentech, Inc.: Klonopin (clonazepam) Recalled for Missing Controlled Substance Labeling

Agency Publication Date: February 13, 2018
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Summary

Genentech, Inc. is recalling 3,192 bottles of Klonopin (clonazepam) 0.5 mg tablets because the outer carton is missing the required 'CIV' indicator, which identifies it as a Schedule IV controlled substance. While the label on the actual bottle inside is correct, the outer packaging does not properly reflect the medication's controlled status. This recall affects 100-count bottles of the 0.5 mg strength that were distributed nationwide.

Risk

The omission of the Schedule IV (CIV) designation on the outer carton may lead to a lack of awareness regarding the medication's potential for abuse or misuse, though the primary bottle label remains accurate.

What You Should Do

  1. Check your Klonopin (clonazepam) 0.5 mg 100-count bottle (NDC 0004-0068-01) for lot number 3141989 with an expiration date of 08/31/2019.
  2. Verify if the outer carton of the medication is missing the 'CIV' symbol, which indicates it is a Schedule IV controlled substance.
  3. Contact your healthcare provider or pharmacist for guidance regarding this labeling error and to discuss your treatment.
  4. Return any unused product to your pharmacy for a refund and contact Genentech, Inc. for further instructions.
  5. Contact 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

๐Ÿ’ฐFull Refund

Contact healthcare provider or pharmacist for guidance and return to pharmacy for refund.

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Klonopin (clonazepam) 0.5 mg Tablets (100-count bottle)
Model:
NDC 0004-0068-01
Lot Numbers:
3141989 (Exp 08/31/2019)
Date Ranges: EXP 08/31/2019

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 79175
Status: Resolved
Manufacturer: Genentech, Inc.
Sold By: pharmacies
Manufactured In: Canada, United States
Units Affected: 3,192 bottles
Distributed To: Nationwide

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.