US Drug Recall Register
Class II · Moderate risk Ongoing Initiated Feb 17, 2025 (2 years ago)

Simethicone 20 mg per 0.3 mL Oral Syringe, Delivers: 0.3 mL, Oral Drops, Mfg By: Rugby…

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

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

What was recalled

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.

Recalling firm
Safecor Health, LLC
Origin
OH, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0251-2025

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.