CLASS II ONGOING Drug recall · Reported 12 Mar 2025 · FDA Enforcement Report
Simethicone 20 mg per Oral Syringe, Delivers:, Oral Drops recalled
Safecor Health is recalling Simethicone 20 mg per Oral Syringe, Delivers:, Oral Drops, distributed nationwide in the US. The recall was initiated on 17 Feb 2025 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0251-2025
- FDA event ID
- 96308
- Recalling firm
- Safecor Health, Columbus, OH
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 17 Feb 2025
- FDA classified
- 5 Mar 2025
- Reported
- 12 Mar 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
Timeline
| 17 Feb 2025 | Recall initiated by company | |
| 5 Mar 2025 | Classified by FDA | +16 days |
| 12 Mar 2025 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
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.
Where it was distributed
Nationwide in the USA
Questions about this recall
Why was it recalled?
Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.
Which lots are affected?
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.
Where was it sold?
Nationwide in the USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
4 other products · FDA event 96308This product is part of a recall event; the main page for the event is Ergocalciferol - Vitamin D Supplement recalled by Safecor Health.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Ergocalciferol - Vitamin D Supplement recalled by Safecor Health | Safecor Health | Packaging Defects | Nationwide | |
| CLASS II | Lorazepam 0.5 mg per Oral Syringe, Delivers:, Oral Concentrate recalled | Safecor Health | Packaging Defects | Nationwide | |
| CLASS II | Ferrous Sulfate 7.5 mg Iron/ Oral Syringe, Delivers recalled | Safecor Health | Packaging Defects | Nationwide | |
| CLASS II | Morphine Sulfate 5 mg per Oral Syringe, Delivers:, Oral Solution recalled | Safecor Health | Packaging Defects | Nationwide |
More recalls from Safecor Health
All 24| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Vitamin B-Complex, Vitamin C & Folic Acid Dietary recalled | Safecor Health | Particulate Matter | OH |
| Drug | CLASS II | Atomoxetine Capsules HCL in unit dose foil strip, strips recalledAtomoxetine | Safecor Health | Labeling Errors | TX |
| Drug | CLASS II | Haloperidol Lactate Injection, 5 mg/mL recalled by Safecor HealthHaloperidol Lactate | Safecor Health | Packaging Defects | MA |
| Drug | CLASS II | Morphine Sulfate 5 mg per Oral Syringe, Delivers:, Oral Solution recalled | Safecor Health | Packaging Defects | Nationwide |
| Drug | CLASS II | Ferrous Sulfate 7.5 mg Iron/ Oral Syringe, Delivers recalled | Safecor Health | Packaging Defects | Nationwide |