Simethicone Oral Syringe Recalled for Defective Delivery System
Safecor Health is recalling Simethicone 20 mg oral syringes due to leakage caused by a defective delivery system. Approximately 10,992 syringes were distributed nationwide.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall of a pharmaceutical product with a manufacturing defect. No illnesses, injuries, or hospitalizations have been reported. The hazard is a functional delivery system defect without reported patient harm, consistent with a voluntary precautionary recall.
Plain-English summary
Safecor Health, LLC is recalling Simethicone 20 mg per 0.3 mL Oral Syringe unit-dose syringes manufactured by Rugby. The recall affects approximately 10,992 syringes distributed nationwide in the United States.
The syringes are being recalled because of a defective delivery system that causes leakage after the oral solution was repackaged into unit-dose syringes. The affected lot numbers are: 24201295 (expires 02/05/2025), 24210364 (expires 02/20/2025), 24231720 (expires 02/27/2025), 24500770 (expires 06/26/2025), 24471182 (expires 06/20/2025), and 25031031 (expires 07/22/2025).
Consumers who possess syringes with any of these lot numbers should stop using them immediately and contact their healthcare provider or pharmacist for proper disposal instructions and to obtain replacement medication.
The recalled product
- Product
- 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.
- Manufacturer
- Safecor Health, LLC
- Category
- Drug
- Hazard
- delivery-system-defect
- leakage
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (12)
- 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.
Distribution
Distributed nationwide across the United States.
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