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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

Valeant Pharmaceuticals North America LLC: Diazepam Rectal Gel Recalled for Missing Lot Number and Expiration Date

Agency Publication Date: August 3, 2018
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Summary

Valeant Pharmaceuticals is recalling 306 cartons of Diazepam Rectal Gel, 2.5 mg Twin Packs (NDC 68682-650-20). These products were distributed without the required lot number or expiration date printed on the outer carton. This missing information prevents patients and caregivers from knowing if the medication has expired or if it is part of a specific batch affected by future safety concerns. Consumers should contact their healthcare provider or pharmacist for guidance on any product missing this information.

Risk

The absence of a lot number and expiration date on the medication's packaging means consumers cannot verify the product's shelf life or effectiveness. This could lead to the use of expired medication, which may not provide the intended therapeutic benefit during a medical emergency.

What You Should Do

  1. Check your medicine for Diazepam Rectal Gel, 2.5 mg, TWIN PACK with NDC number 68682-650-20.
  2. Examine the outer carton of the package to see if the lot number and expiration date are visible. The affected product corresponds to Lot NBBN with an expiration date of 02/22.
  3. If you have a carton that is missing this information or matches lot NBBN, contact your healthcare provider or pharmacist immediately for guidance on using the product.
  4. Return any unused product to your pharmacy for a refund and contact Valeant Pharmaceuticals North America LLC for further instructions.
  5. For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

💰Full Refund

Return for refund and consult healthcare professionals.

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

Affected Products

Product: Diazepam Rectal Gel, 2.5 mg, TWIN PACK
Model:
NDC 68682-650-20
Lot Numbers:
NBBN (Exp 02/22)
Date Ranges: 02/22

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 80662
Status: Resolved
Manufacturer: Valeant Pharmaceuticals North America LLC
Manufactured In: United States
Units Affected: 306 cartons
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 · 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.