Simethicone Oral Syringes Recalled Due to Leakage Issue

Safecor Health, LLC has issued a voluntary nationwide recall of simethicone 20 mg per 0.3 mL oral syringes due to a defective delivery system that may cause leakage after the solution is repackaged into unit-dose syringes. The recall affects 10992 oral syringes from multiple lots (24201295, 24210364, 24231720, 24500770, 24471182, and 25031031) with expiration dates ranging from February 2025 to July 2025. The affected product, originally manufactured by Rugby and packaged by Safecor Health, was distributed across the US. The recall was initiated on February 17, 2025, and classified as a Class II recall by the FDA, indicating that use of the defective product may cause temporary or medically reversible adverse health effects.

The recall was prompted by observed leakage in the oral syringes, which may result in inaccurate dosing or contamination of the medication. No adverse events have been reported at this time, but pharmacists and health care providers are advised to discontinue use of the recalled syringes and return them in accordance with the recall instructions. Customers were notified of the issue via letter, and the recall remains ongoing. As of now, no official press release has been issued by Safecor Health regarding this recall.

Simethicone is an over-the-counter antiflatulent used to relieve gas, bloating, and discomfort caused by excess stomach or intestinal gas. It is commonly prescribed for infants and adults to alleviate digestive discomfort. Pharmacists should verify their inventory and ensure that alternative products are available to prevent potential dosing inaccuracies due to the defective syringes. Any adverse reactions or quality concerns should be reported to the FDA MedWatch program.