Recalls / Active ingredient / Dimethicone

Dimethicone

7 FDA drug recalls involving the active ingredient “Dimethicone” — 1 Class I.

Date	Class	Product	Firm
2025-12-19	Class II	INON ACE Antacid tablets (magnesium aluminosilicate, magnesium hydroxide and simethicone), 75-count bottle, Ma	Sato Pharmaceutical Co., Ltd
2024-05-28	Class II	Little Remedies Gas Relief Drops (Simethicone/Antigas), packaged in 1 fl. oz. (30 mL) bottle with dropper, Dis	Denison Pharmaceuticals, LLC
2022-04-13	Class II	E-Z-Gas II, Effervescent Granules, Net Weight: 4 g, 50 packets per box, MFG: Bracco Diagnostics Inc., NDC 0270	Mckesson Medical-Surgical Inc. Corporate Office
2016-07-29	Class I	COMFORT SHIELD (dimethicone) Barrier Cream Cloths, 3%, packaged as impregnated cloths wrapped in flexible pack	Sage Products LLC
2016-07-29	Class II	COMFORT SHIELD (dimethicone) Barrier Cream Cloths, 3%, packaged as impregnated cloths wrapped in flexible pack	Sage Products LLC
2014-09-18	Class III	E-Z- GAS II EFFERVESCENT GRANULES Antacid/Antiflatulent ,4 g (0.14 oz), 50 -count box, Rx Only, Manufactured	Bracco Diagnostic Inc
2014-08-27	Class II	Comfort Shield Barrier Cream Cloths with dimethicone a) 8 count NDC 53462-915-80, b) 24 count NDC 53462-915-60	Sage Products Inc