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K.C. Pharmaceuticals, Inc FDA Recalls
10 recalls on file across drugs, 0 of them Class I and 10 still open. This firm is not matched to a listed company.
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Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| STERILE EYE DROPS SOOTHING TEARS (polyethylene glycol 400 0.4% and propylene glycol 0.3%), 0.5 OZ 0.5 fl oz (15 mL) botClass IIMar 3, 2026Lack of Assurance of Sterility |
| Ultra Lubricating Eye Drops (polyethylene 400 0.4%, propylene glycol 0.3%), Sterile, 0.5 FL OZ (15mL) bottles; a) LEADERClass IIMar 3, 2026Lack of Assurance of Sterility |
| Sterile Eye Drops ORIGINAL FORMULA (tetrahydrozoline HCl 0.05%), 0.5 FL OZ (15mL) bottles; a) Good Sense Sterile Eye DroClass IIMar 3, 2026Lack of Assurance of Sterility |
| Dry Eye Relief Eye Drops, (glycerin 0.2%, hypromellose 0.2% and polyethylene glycol 400 1%) 0.5 FL OZ (15 mL) bottles; aClass IIMar 3, 2026Lack of Assurance of Sterility |
| EYE DROPS Advanced Relief, (dextran 70 0.1%, polyethylene glycol 400 1% and tetrahydrozoline HCl 0.05%), 0.5 FL OZ (15 mClass IIMar 3, 2026Lack of Assurance of Sterility |
| Artificial Tears Sterile Lubricant Eye Drops (polyvinyl alcohol 0.5%, povidone 0.6%), 0.5 FL OZ (15 mL) bottles; a) LEADClass IIMar 3, 2026Lack of Assurance of Sterility |
| Sterile EYE DROPS REDNESS LUBRICANT (glycerin 0.25% and naphazoline HCl 0.012%), 0.5 fl oz (15 mL) bottles; a) IndustriaClass IIMar 3, 2026Lack of Assurance of Sterility |
| Sterile EYE DROPS AC (tetrahydrozoline HCl 0.05%, zinc sulfate 0.25%), 0.5 fl. oz. (15 mL) bottles; a) Best Choice, PROUClass IIMar 3, 2026Lack of Assurance of Sterility |
| Dry Eye Relief Lubricant Eye Drops, (Glycerin 0.2%, Hypromellose 0.2 %, Polyethylene glycol 400 1%), 0.5 FL OZ (15mL) boClass IIJun 13, 2023CGMP Deviations: good manufacturing deficiencies related to |
| Original Eye Drops; Redness Reliever; (Tetrahydrozoline HCl), 0.05%, 0.5 FL OZ (15mL); distributed by a) Original FormulClass IIJun 13, 2023CGMP Deviations: good manufacturing deficiencies related to |