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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

Leading Pharma, LLC: Lorazepam Tablets Recalled for Incorrect Strength on Label

Agency Publication Date: November 20, 2017
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Summary

Leading Pharma, LLC is recalling 2,952 bottles of Lorazepam Tablets (lorazepam) because the bottles are labeled as 0.5 mg strength but actually contain 1 mg tablets. This recall affects 500-count bottles of the prescription medication distributed nationwide across the United States. Consumers who take a 1 mg tablet instead of the prescribed 0.5 mg dose will receive double the intended medication, which can lead to excessive sedation or other adverse effects. You should contact your healthcare provider or pharmacist immediately if you believe you have the affected product.

Risk

Taking double the intended dose of lorazepam poses a significant risk of excessive central nervous system depression, which can cause extreme drowsiness, confusion, and impaired coordination. This labeling error increases the likelihood of accidental overdose, especially in patients who are sensitive to the medication or are taking other sedatives.

What You Should Do

  1. Check your prescription bottle of Lorazepam Tablets, USP CIV, 0.5 mg (500-count) for NDC number 69315-904-05 and Lot #E00717.
  2. Compare the tablets inside the bottle with the strength listed on the label; the 1 mg tablets found inside were incorrectly placed in bottles labeled as 0.5 mg.
  3. If you have a bottle from Lot #E00717, stop taking the medication and contact your healthcare provider or pharmacist immediately for guidance.
  4. Return any unused tablets from the affected lot to the pharmacy where they were purchased to receive a refund and a correct replacement prescription.
  5. Contact Leading Pharma, LLC at their Fairfield, New Jersey location for more information regarding this recall.
  6. For additional questions or to report a side effect, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

๐Ÿ’ฐFull Refund

Pharmacy refund and healthcare guidance

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

Affected Products

Product: Lorazepam Tablets, USP CIV, 0.5 mg (500-count bottle)
Model:
NDC 69315-904-05
Lot Numbers:
E00717

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 78471
Status: Resolved
Manufacturer: Leading Pharma, LLC
Sold By: pharmacies
Manufactured In: United States
Units Affected: 2952 500-count 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.