Morphine Sulfate 5 mg per 0.25 mL Oral Syringe, Delivers: 0.25 mL, Oral Solution, Rx Only, Mfg by: Hikma, Pkg by: Safecor Health, LLC, Columbus, OH 43204, NDC: a) 00406800312, b) 00406800330, c) 00054051750.

Recall Number: D-0254-2025

Firm: Safecor Health, LLC

Classification: Class II

Status: Ongoing

Report Date: 20250312

Initiation Date: 20250217

Termination Date:

Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.

Morphine Sulfate 5 mg per 0.25 mL Oral Syringe, Delivers: 0.25 mL, Oral Solution, Rx Only, Mfg by: Hikma, Pkg by: Safecor Health, LLC, Columbus, OH 43204, NDC: a) 00406800312, b) 00406800330, c) 00054051750.