K.C. Pharmaceuticals, Inc

FDA Regulatory Profile

Summary

Total Recalls
10
510(k) Clearances
0
Inspections
10
Compliance Actions
2

Known Names

k c pharmaceuticals, k. c. pharmaceuticals

Recent Recalls

NumberClassProductDate
D-0412-2026Class IIUltra Lubricating Eye Drops (polyethylene 400 0.4%, propylene glycol 0.3%), Sterile, 0.5 FL OZ (15mLMarch 3, 2026
D-0416-2026Class IIArtificial Tears Sterile Lubricant Eye Drops (polyvinyl alcohol 0.5%, povidone 0.6%), 0.5 FL OZ (15 March 3, 2026
D-0411-2026Class IIDry Eye Relief Eye Drops, (glycerin 0.2%, hypromellose 0.2% and polyethylene glycol 400 1%) 0.5 FL OMarch 3, 2026
D-0414-2026Class IISterile EYE DROPS REDNESS LUBRICANT (glycerin 0.25% and naphazoline HCl 0.012%), 0.5 fl oz (15 mL) bMarch 3, 2026
D-0410-2026Class IIEYE DROPS Advanced Relief, (dextran 70 0.1%, polyethylene glycol 400 1% and tetrahydrozoline HCl 0.0March 3, 2026
D-0409-2026Class IISterile EYE DROPS AC (tetrahydrozoline HCl 0.05%, zinc sulfate 0.25%), 0.5 fl. oz. (15 mL) bottles; March 3, 2026
D-0415-2026Class IISTERILE EYE DROPS SOOTHING TEARS (polyethylene glycol 400 0.4% and propylene glycol 0.3%), 0.5 OZ 0March 3, 2026
D-0413-2026Class IISterile Eye Drops ORIGINAL FORMULA (tetrahydrozoline HCl 0.05%), 0.5 FL OZ (15mL) bottles; a) Good SMarch 3, 2026
D-0897-2023Class IIOriginal Eye Drops; Redness Reliever; (Tetrahydrozoline HCl), 0.05%, 0.5 FL OZ (15mL); distributed bJune 13, 2023
D-0898-2023Class IIDry Eye Relief Lubricant Eye Drops, (Glycerin 0.2%, Hypromellose 0.2 %, Polyethylene glycol 400 1%),June 13, 2023