FDAFDA · Food and drugs·Recall number D-0254-2025
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.
Published March 12, 2025 · Recall initiated: February 17, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Safecor Health, LLC
- Distributor
- Nationwide in the USA
- Lot
- Lot #s: a) 24220672, Exp 02/19/2025; 24280145, Exp 03/18/2025; 24240711, Exp 03/19/2025; b) 24180729, Exp 01/23/2025; 25030427, Exp 07/17/2025; c) 24360865, 24360864, Exp 03/31/2025; 24480235, Exp 06/21/2025.
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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