Class II

Drug Recall: 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.

Safecor Health, LLC · February 17, 2025

Reason for Recall

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

Distribution

Nationwide in the USA

States Affected

NATIONWIDE

Quantity Affected

10992 Oral Syringes

Source: FDA (openFDA Drug Enforcement)

Recall number: D-0251-2025

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.