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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

Lorazepam Injection Recalled for Impurity and Degradation Specifications

Agency Publication Date: July 31, 2025
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Summary

Hikma Pharmaceuticals USA Inc. is recalling 382,775 vials of Lorazepam Injection (lorazepam), 2 mg/mL, because the product failed to meet specifications for impurities and degradation compounds. This voluntary recall affects cartons containing 25 vials (1mL each) that were distributed nationwide. Using medication that has degraded or contains excessive impurities can affect the safety and effectiveness of the drug.

Risk

Medications that exceed impurity specifications may not perform as intended or could potentially cause unexpected side effects. Because this medication is an injectable drug often used in clinical settings, maintaining high purity standards is critical for patient safety.

What You Should Do

  1. This recall affects Hikma brand Lorazepam Injection, USP, 2 mg/mL, sold in cartons of 25 vials (1mL per vial) with NDC number 0641-6044-25.
  2. Specifically, consumers and healthcare providers should check for lot number K24118 with an expiration date of 10/31/2026.
  3. This is a sterile injectable medication typically administered in hospitals or clinics. Stop using the recalled product immediately.
  4. Contact Hikma Pharmaceuticals USA Inc. or your distributor to arrange for the return of any remaining inventory from the affected lot.
  5. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions regarding this recall.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return.

Affected Products

Product: Lorazepam Injection, USP (2 mg/mL)by Hikma
Variants: 2 mg/mL, 1mL vials, 25 x 1mL vials/carton
Lot Numbers:
K24118 (Exp 10/31/2026)
NDC:
0641-6044-25

Manufactured by Hikma Berkeley Heights, NJ 07922; Recall #: D-0551-2025; Quantity: 382,775 1mL vials.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97294
Status: Active
Manufacturer: Hikma Pharmaceuticals USA Inc.
Sold By: Wholesalers; Distributors; Hospitals; Clinical Pharmacies
Manufactured In: United States
Units Affected: 382,775 1mL vials
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.