The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0251-2025·Announced 2025-03-12

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.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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
Affected units
10,992

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.

Part of a larger recall action

This product is one of 5 recalled by Safecor Health, LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 5 products in this recall →

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