Recalls / Active ingredient / Propylene Glycol

Propylene Glycol

8 FDA drug recalls involving the active ingredient “Propylene Glycol” — 2 Class I.

Date	Class	Product	Firm
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
2025-12-31	Class II	Vista Meibo Tears Propylene Glycol 0.6% w/v Eye Drops Advanced Dry Eye Relief Revitalizing Formula, 10 ml (1/3	Wizcure Pharmaa Private Limited
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.
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
2022-06-29	Class II	Systane Balance, Lubricant Eye Drops, Propylene Glycol 0.6% lubricant, Restorative Formula, Sterile, 10 mL (1/	Mckesson Medical-Surgical Inc. Corporate Office