Simethicone Per Syringe recalls

The FDA has published 1 recall involving Simethicone Per Syringe since 2025. The latest was reported on 12 Mar 2025. Most were for packaging defects. Recalls usually affect specific lots, not every bottle on the market. Check the lot number on each recall page before acting.

Total recalls1since 2025
Last 12 months0reported
Class I00% of total
Ongoing1latest 12 Mar 2025

Recalls per month, last 24 months

click a bar for that month

Severity split

Class I 0 0%Class II 1 100%Class III 0 0%

Why simethicone per syringe is recalled

Companies

By year

Ongoing simethicone per syringe recalls

1 active
ReportedClassRecallCompanyReasonWhere
DrugCLASS IISimethicone 20 mg per Oral Syringe, Delivers:, Oral Drops recalledSafecor HealthPackaging DefectsNationwide

All simethicone per syringe recalls, newest first

1 total
ReportedClassRecallCompanyReasonWhere
DrugCLASS IISimethicone 20 mg per Oral Syringe, Delivers:, Oral Drops recalledSafecor HealthPackaging DefectsNationwide

Should you stop taking Simethicone Per Syringe?

Not on your own. Most recalls affect specific lots from one manufacturer, and stopping a prescription suddenly can be riskier than the defect. Check your lot number and NDC against the recall, then call the pharmacy that dispensed it for a replacement.