Why it was recalled
Failed Impurities/Degradation Specifications: An out-of-Specification for total related compounds
Product description
Lorazepam Injection, USP, 2 mg/mL, 25 x 1mL vials/carton, Rx Only, Manufactured by: Hikma Berkeley Heights, NJ 07922, NDC# 0641-6044-25
Lot numbers, UPCs & expiration codes
Lot # K24118, exp. date 10/31/2026
Where it was sold
Distributed Nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0551-2025
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Jul 22, 2025
- FDA report date
- Aug 6, 2025
- Quantity
- 382,775 1mL vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Hikma Pharmaceuticals USA Inc.
Original FDA data
Every field from FDA enforcement report D-0551-2025, exactly as published.
Show all FDA fields
- City
- Cherry Hill
- State
- NJ
- Status
- Ongoing
- Country
- United States
- Event ID
- 97294
- Address
- 2 Esterbrook Ln
- Code information
- Lot # K24118, exp. date 10/31/2026
- Postal code
- 08003-4002
- Report date
- Aug 6, 2025
- Product type
- Drugs
- Recall number
- D-0551-2025
- Classification
- Class II
- Recalling firm
- Hikma Pharmaceuticals USA Inc.
- Product quantity
- 382,775 1mL vials
- Reason for recall
- Failed Impurities/Degradation Specifications: An out-of-Specification for total related compounds
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Lorazepam Injection, USP, 2 mg/mL, 25 x 1mL vials/carton, Rx Only, Manufactured by: Hikma Berkeley Heights, NJ 07922, NDC# 0641-6044-25
- Distribution pattern
- Distributed Nationwide in the USA
- Recall initiation date
- Jul 22, 2025
- Initial firm notification
- Letter
- Center classification date
- Jul 31, 2025