K C Pharmaceuticals recalls
K C Pharmaceuticals appears in 23 official U.S. recall notices indexed by RecallRadar, most recently on 2026-10-14.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 23 |
|---|---|
| Published | 2013-03-20 to 2026-10-14 |
| By agency | FDA Drug (23) |
| By classification | Class II (19), Class III (4) |
| By status | ongoing (18), terminated (5) |
| Distribution named in notices | US |
Recalls
- Sterile Lubricant Dry Eye Relief Eye Drops, 0.5 FL OZ (15 mL)
FDA Drug · Class II · 2026-10-14 · K C Pharmaceuticals
Reason: Lack of Assurance of Sterility - Sterile EYE DROPS AC (tetrahydrozoline HCl 0.05%, zinc sulfate 0.25%), 0.5 fl. oz. (15 mL) bottles
FDA Drug · Class II · 2026-10-14 · K C Pharmaceuticals
Reason: Lack of Assurance of Sterility - Sterile EYE DROPS Advanced Relief, (dextran 70, 0.1%, polyethylene glycol 400 1% and tetrahydrozoline HCl 0.05%), 0.5 FL OZ (15 mL) bottles…
FDA Drug · Class II · 2026-10-14 · K C Pharmaceuticals
Reason: Lack of Assurance of Sterility - Artificial Tears Sterile Lubricant Eye Drops (polyvinyl alcohol 0.5%, povidone 0.6%), 0.5 FL OZ (15 mL) bottles
FDA Drug · Class II · 2026-10-14 · K C Pharmaceuticals
Reason: Lack of Assurance of Sterility - Eye Drops MAXIMUM, REDNESS RELIEF, Sterile, 1/2 FL OZ (0.5 ML)
FDA Drug · Class II · 2026-10-14 · K C Pharmaceuticals
Reason: Lack of Assurance of Sterility - Sterile Eye Drops Redness Relief (Glycerin 0.25%, Naphazoline HCl 0.02% Lubricant
FDA Drug · Class II · 2026-10-14 · K C Pharmaceuticals
Reason: Lack of Assurance of Sterility - Sterile Eye Drops, ORIGINAL, Tetrahydrozoline HCl 0.05% Redness Reliever ¿ Fast Acting Formula) Product size: 0.5 fl oz (15 mL)
FDA Drug · Class II · 2026-10-14 · K C Pharmaceuticals
Reason: Lack of Assurance of Sterility - Sterile High Performance Ultra Lubricating Eye Drops (Polyethylene Glycol 400, 0.4% Relieves Dry and Irritated Eyes) Product size: 0.5 fl o…
FDA Drug · Class II · 2026-10-14 · K C Pharmaceuticals
Reason: Lack 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
FDA Drug · Class II · 2026-04-08 · K C Pharmaceuticals
Reason: Lack of Assurance of Sterility - STERILE EYE DROPS SOOTHING TEARS (polyethylene glycol 400 0.4% and propylene glycol 0.3%), 0.5 OZ 0.5 fl oz (15 mL) bottles
FDA Drug · Class II · 2026-04-08 · K C Pharmaceuticals
Reason: Lack of Assurance of Sterility - Sterile Eye Drops ORIGINAL FORMULA (tetrahydrozoline HCl 0.05%), 0.5 FL OZ (15mL) bottles
FDA Drug · Class II · 2026-04-08 · K C Pharmaceuticals
Reason: Lack 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 mL) bottles, Sterile
FDA Drug · Class II · 2026-04-08 · K C Pharmaceuticals
Reason: Lack of Assurance of Sterility - Ultra Lubricating Eye Drops (polyethylene 400 0.4%, propylene glycol 0.3%), Sterile, 0.5 FL OZ (15mL) bottles
FDA Drug · Class II · 2026-04-08 · K C Pharmaceuticals
Reason: Lack of Assurance of Sterility - Artificial Tears Sterile Lubricant Eye Drops (polyvinyl alcohol 0.5%, povidone 0.6%), 0.5 FL OZ (15 mL) bottles
FDA Drug · Class II · 2026-04-08 · K C Pharmaceuticals
Reason: Lack of Assurance of Sterility - Sterile EYE DROPS REDNESS LUBRICANT (glycerin 0.25% and naphazoline HCl 0.012%), 0.5 fl oz (15 mL) bottles
FDA Drug · Class II · 2026-04-08 · K C Pharmaceuticals
Reason: Lack of Assurance of Sterility - Sterile EYE DROPS AC (tetrahydrozoline HCl 0.05%, zinc sulfate 0.25%), 0.5 fl. oz. (15 mL) bottles
FDA Drug · Class II · 2026-04-08 · K C Pharmaceuticals
Reason: Lack 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) bottle, packaged in a…
FDA Drug · Class II · 2023-07-19 · K C Pharmaceuticals
Reason: CGMP Deviations: good manufacturing deficiencies related to a lack of documentation of the fill line. - Original Eye Drops
FDA Drug · Class II · 2023-07-19 · K C Pharmaceuticals
Reason: CGMP Deviations: good manufacturing deficiencies related to a lack of documentation of the fill line. - Eye Drops (Tetrahydrozoline HCl 0.05%), 0.5 FL OZ (15 mL) Bottles, Over the Counter
FDA Drug · Class III · 2014-12-31 · K C Pharmaceuticals
Reason: CGMP Deviations: Active Pharmaceutical Ingredient (API) used for manufacture was stored in a non-GMP compliant warehouse at S.I.M.S., Italy. - Eye Drops A.C. (Tetrahydrozoline HCl 0.05%, Zinc sulfate 0.25%), 0.5 FL OZ (15 mL) Bottles, Over the Counter
FDA Drug · Class III · 2014-12-31 · K C Pharmaceuticals
Reason: CGMP Deviations: Active Pharmaceutical Ingredient (API) used for manufacture was stored in a non-GMP compliant warehouse at S.I.M.S., Italy. - Eye Drops Advanced Relief (Dextran 70 0.1%, Polyethylene glycol 400 1%, Povidone 1%, Tetrahydrozoline HCl 0.05%), 0.5 FL OZ (15 mL) Bottles…
FDA Drug · Class III · 2014-12-31 · K C Pharmaceuticals
Reason: CGMP Deviations: Active Pharmaceutical Ingredient (API) used for manufacture was stored in a non-GMP compliant warehouse at S.I.M.S., Italy. - Eye Drops Industrial Strength (Polyethylene glycol 400 1%, Tetrahydrozoline HCl 0.05%), 0.5 FL OZ (15 mL) Bottles, Over the Counter
FDA Drug · Class III · 2014-12-31 · K C Pharmaceuticals
Reason: CGMP Deviations: Active Pharmaceutical Ingredient (API) used for manufacture was stored in a non-GMP compliant warehouse at S.I.M.S., Italy. - Eye Drops advanced relief (Dextran 70 0.1%, Polyethylene glycol 400 1%, Povidone 1%, Tetrahydrozoline HCl 0.05%) ophthalmic solution, 1/2 f…
FDA Drug · Class II · 2013-03-20 · K C Pharmaceuticals
Reason: Labeling: Label Mix-Up: Incorrect back labeling of the immediate container of eye drops (unit carton and front label are correct) which do not list three active ingredients: Dextran 70, PEG 400, and povidone.