Class II · Moderate risk
Clear Eyes Redness Relief
Lack of Assurance of Sterility
Is Naphazoline recalled?
Yes — there is an active recall. 7 ongoing FDA recalls mention Naphazoline (26 total). Check the affected lots below.
Most common reason: cGMP deviation (14 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Naphazoline. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Naphazoline recalls in 2026
7 initiated in 2026, 26 in total — newest first
Class II · Moderate risk
Clear Eyes Redness Relief
Lack of Assurance of Sterility
Class II · Moderate risk
Rohto Cooling Eye Drops Cool Relief
Lack of Assurance of Sterility
Class II · Moderate risk
Rohto Cooling Eye Drops Optic Glow
Lack of Assurance of Sterility
Class II · Moderate risk
Rohto Cooling Eye Drops Max Strength
Lack of Assurance of Sterility
Class II · Moderate risk
Rohto Cooling Eye Drops Max Strength
Lack of Assurance of Sterility
Class II · Moderate risk
Sterile EYE DROPS REDNESS LUBRICANT
Lack of Assurance of Sterility
Class II · Moderate risk
Naphcon A eye drops
CGMP Deviations: products were stored outside the drug label specifications.
Class II · Moderate risk
Clear Eyes Redness Relief Hand Pocket Pal Tray Display
CGMP Deviations: concerns regarding the sufficiency of Quality Assurance controls over critical systems in the manufacturing facility that could impact the product quality of the finished products.
Class II · Moderate risk
Clear eyes REDNESS RELIEF
CGMP Deviations: concerns regarding the sufficiency of Quality Assurance controls over critical systems in the manufacturing facility that could impact the product quality of the finished products.
Class II · Moderate risk
Clear Eyes Redness Relief Handy Pocket Pal Club Pak Display
CGMP Deviations: concerns regarding the sufficiency of Quality Assurance controls over critical systems in the manufacturing facility that could impact the product quality of the finished products.
Class II · Moderate risk
Clear Eyes Maximum Itchy Eye Relief Sidekick Floor Stand Display
CGMP Deviations: concerns regarding the sufficiency of Quality Assurance controls over critical systems in the manufacturing facility that could impact the product quality of the finished products.
Class II · Moderate risk
Clear Eyes Maximum Redness Relief Club Pack Display
CGMP Deviations: concerns regarding the sufficiency of Quality Assurance controls over critical systems in the manufacturing facility that could impact the product quality of the finished products.
Class II · Moderate risk
Clear Eyes Maximum Itchy Eye Relief Sidekick Floor Stand Display
CGMP Deviations: concerns regarding the sufficiency of Quality Assurance controls over critical systems in the manufacturing facility that could impact the product quality of the finished products.
Class II · Moderate risk
Clear Eyes Redness Relief Club Pack Display
CGMP Deviations: concerns regarding the sufficiency of Quality Assurance controls over critical systems in the manufacturing facility that could impact the product quality of the finished products.
Class II · Moderate risk
Clear Eyes Assorted Sidekick Floor Stand Display
CGMP Deviations: concerns regarding the sufficiency of Quality Assurance controls over critical systems in the manufacturing facility that could impact the product quality of the finished products.
Class II · Moderate risk
Clear Eyes Maximum Redness and Itchy Eye Relief Sidekick Display
CGMP Deviations: concerns regarding the sufficiency of Quality Assurance controls over critical systems in the manufacturing facility that could impact the product quality of the finished products.
Class II · Moderate risk
Clear Eyes Assorted IRC Display
CGMP Deviations: concerns regarding the sufficiency of Quality Assurance controls over critical systems in the manufacturing facility that could impact the product quality of the finished products.
Class II · Moderate risk
Clear eyes MAXIMUM REDNESS RELIEF
CGMP Deviations: concerns regarding the sufficiency of Quality Assurance controls over critical systems in the manufacturing facility that could impact the product quality of the finished products.
Class II · Moderate risk
Clear eyes MAXIMUM ITCHY EYE RELIEF
CGMP Deviations: concerns regarding the sufficiency of Quality Assurance controls over critical systems in the manufacturing facility that could impact the product quality of the finished products.
Class II · Moderate risk
Clear eyes REDNESS RELIEF
CGMP Deviations: concerns regarding the sufficiency of Quality Assurance controls over critical systems in the manufacturing facility that could impact the product quality of the finished products.
Class II · Moderate risk
Clear eyes REDNESS RELIEF
CGMP Deviations: concerns regarding the sufficiency of Quality Assurance controls over critical systems in the manufacturing facility that could impact the product quality of the finished products.
Class II · Moderate risk
Dorama-Neo
Lack of Assurance of Sterility: Firm failed to establish an adequate system for monitoring environmental conditions in aseptic processing areas.
Class II · Moderate risk
Sato Clear
Lack of Assurance of Sterility: Firm failed to establish an adequate system for monitoring environmental conditions in aseptic processing areas.
Class II · Moderate risk
Optic Splash
Lack of Assurance of Sterility: Firm failed to establish an adequate system for monitoring environmental conditions in aseptic processing areas.
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