FDAFDA · Food and drugs·Recall number D-0251-2025
Simethicone 20 mg per 0.3 mL Oral Syringe, Delivers: 0.3 mL, Oral Drops, Mfg By: Rugby, Pkg by: Safecor Health, LLC, Columbus, OH 43204, NDC: 00536130375.
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: 24201295, Exp 02/05/2025; 24210364, Exp 02/20/2025; 24231720, Exp 02/27/2025; 24500770, Exp 06/26/2025; 24471182, Exp 06/20/2025; 25031031, Exp 07/22/2025.
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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