Recalls / Active ingredient / Polyethylene Glycol 400

Polyethylene Glycol 400

10 FDA drug recalls involving the active ingredient “Polyethylene Glycol 400” — 2 Class I.

Date	Class	Product	Firm
2026-03-03	Class II	Dry Eye Relief Eye Drops, (glycerin 0.2%, hypromellose 0.2% and polyethylene glycol 400 1%) 0.5 FL OZ (15 mL)	K.C. Pharmaceuticals, Inc
2026-03-03	Class II	EYE DROPS Advanced Relief, (dextran 70 0.1%, polyethylene glycol 400 1% and tetrahydrozoline HCl 0.05%), 0.5 F	K.C. Pharmaceuticals, Inc
2026-03-03	Class II	Sterile EYE DROPS AC (tetrahydrozoline HCl 0.05%, zinc sulfate 0.25%), 0.5 fl. oz. (15 mL) bottles; a) Best Ch	K.C. Pharmaceuticals, Inc
2026-03-03	Class II	Ultra Lubricating Eye Drops (polyethylene 400 0.4%, propylene glycol 0.3%), Sterile, 0.5 FL OZ (15mL) bottles;	K.C. Pharmaceuticals, Inc
2025-04-23	Class II	Lubricant Eye Drops Solution, Polyethylene Glycol 400 0.4% Eye Lubricant, Propylene Glycol 0.3% Eye Lubricant,	BRS Analytical Services, LLC
2023-11-13	Class I	Leader brand Dry Eye Relief (Polyethylene glycol 400 0.4% and Propylene glycol 0.3%) packaged in 0.33 FL OZ (1	Kilitch Healthcare India Limited
2023-10-31	Class I	LEADER brand Dry Eye Relief (Polyethylene Glycol 400, 0.4% Propylene Glycol, 0.3%); 0.33 FL OZ (10 mL) dropper	Cardinal Health Inc.
2023-06-13	Class II	Dry Eye Relief Lubricant Eye Drops, (Glycerin 0.2%, Hypromellose 0.2 %, Polyethylene glycol 400 1%), 0.5 FL OZ	K.C. Pharmaceuticals, Inc
2022-06-29	Class II	Systane, Lubricant Eye Drops, Polyethylene Glycol 400 0.4% Lubricant, Propylene Glycol 0.3% Lubricant, Origina	Mckesson Medical-Surgical Inc. Corporate Office
2014-12-04	Class III	Eye Drops Advanced Relief (Dextran 70 0.1%, Polyethylene glycol 400 1%, Povidone 1%, Tetrahydrozoline HCl 0.05	K C Pharmaceuticals Inc