Class II
Ongoing
Lorazepam Injection, USP, 2 mg/mL, 25 x 1mL vials/carton, Rx Only, Manufactured by: Hikma Berkeley Heights, NJ 07922, NDC# 0641-6044-25
- Company
- Hikma Pharmaceuticals Usa Inc.
- Recall Initiated
- July 22, 2025
- Posted
- August 6, 2025
- Recall Number
- D-0551-2025
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 382,775 1mL vials
- Firm Location
- Cherry Hill, NJ, United States
Reason for Recall
Failed Impurities/Degradation Specifications: An out-of-Specification for total related compounds
Distribution
Distributed Nationwide in the USA
Lot / Code Info
Lot # K24118, exp. date 10/31/2026
More recalls by Hikma Pharmaceuticals Usa Inc.
Acetaminophen Injection, 1,000 mg per 100 mL (10 mg/mL), 100 mL Single Dose bags, For Intravenous Us...
Aug 28, 2024 · Class I
Infumorph (Preservative-free Morphine Sulfate Sterile Solution), 20 mL ampul, Rx only, Manufactured...
Mar 27, 2024 · Class II
Lorazepam Injection, USP, 2mg/mL, 1 mL vial (NDC 0641-6044-01), packaged in 25 x 1 mL Vials per cart...
May 24, 2023 · Class II
Other recent Class II Drug recalls
Vista Tears Polyethylene Glycol 400 0.4% w/v, Propylene Glycol 0.3% w/v Eye Drops, Dry Eye Relief, L...
Wizcure Pharmaa Private Limited
· Mar 4, 2026
Amantadine HCl, Capsules, UPS, 100 mg, 50 Capsules (5 x 10) unit dose, Rx Only, Manufactured for: Av...
Avkare
· Mar 4, 2026
Agebox iKids-Growth (Day Formula) capsules, 60-count bottles, Manufactured Exclusively For: AGEBOX I...
Agebox
· Mar 4, 2026
Adbry, (tralokinumab-ldrm) injection, 300 mg/2mL, Packaged as a) 1 x Single dose Autoinjector, SAMPL...
Leo Pharma Inc
· Mar 4, 2026
Pro Numb Tattoo Numbing Spray, For Sensitive Skin, 4% Lidocaine, [1FL OZ/28.4 ML or 4 oz/120 mL] per...
Pro Numb Tattoo Numbing Spray Llc
· Feb 18, 2026