Class II · Moderate risk
Clear Eyes Redness Relief
Lack of Assurance of Sterility
Sterility & contamination
A product that must be sterile could not be assured sterile, or was contaminated. A top reason for injectables, eye drops and IV products - loss of sterility assurance can lead to serious infections.
6,317 FDA drug recalls with this cause, newest first.
This is the single biggest cause in the register by a wide margin. It covers products that had to be sterile - injectables, eye drops, certain ointments - but could not be verified sterile, or were found contaminated during testing. Most of these recalls come from compounding pharmacies and outsourcing facilities after an FDA inspection finds gaps in how sterile products were made. Sterility failures are treated seriously because the products involved have the least room for error, going straight into the bloodstream or the eye.
- Total recalls
- 6,317
- Class I (high risk)
- 150
- Currently ongoing
- 692
- Most recent
- Sep 15, 2026
Most-cited firms for this cause
- The Compounding Pharmacy of America383
- Central Admixture Pharmacy Services, Inc.269
- Franck's Lab Inc., d.b.a. Franck's Compounding Lab198
- First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy140
- Altaire Pharmaceuticals, Inc.135
- Vita Pharmacy, LLC dba Talon Compounding Pharmacy130
- Martin Avenue Pharmacy, Inc.118
- Assurance Infusion118
Class II · Moderate risk
Clear Eyes Redness Relief
Lack of Assurance of Sterility
Class II · Moderate risk
Dopamine HCl Inj.
Lack of Assurance of Sterility
Class II · Moderate risk
AvKare Carboxymethylcellulose Sodium Ophthalmic Solution 0.5%
Lack of Assurance of Sterility
Class II · Moderate risk
Lubricant Eye Drops-Cameron Pharmaceuticals
Lack of Assurance of Sterility
Class II · Moderate risk
Major LubriFresh P.M. Nighttime Ointment
Lack of Assurance of Sterility
Class II · Moderate risk
TRP The Relief Products* Gentle Eyes Lubricant Eye Drops
Lack of Assurance of Sterility
Class II · Moderate risk
Reliable-1 Laboratories Lubricating Tears
Lack of Assurance of Sterility
Class II · Moderate risk
Walgreens Lubricant Eye Drops
Lack of Assurance of Sterility
Class II · Moderate risk
Walgreens Lubricant Eye Drops
Lack of Assurance of Sterility
Class II · Moderate risk
Reliable -1 Laboratories
Lack of Assurance of Sterility
Class II · Moderate risk
AvKare Carboxymethylcellulose Sodium Ophthalmic Solution 0.5%
Lack of Assurance of Sterility
Class I · High risk
Epinephrine Injection
Presence of Particulate Matter and Lack of Assurance of Sterility. Particulate matter identified as nylon, cellulosic, acrylic, polyethylene and glass and broken and leaking vials.
Class II · Moderate risk
CLEAR EYES Maximum Itchy Eye Relief
Lack of assurance of sterility. The recall is due to potential contamination
Class II · Moderate risk
Libtayo (cemiplimab-rwlc)
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 Dry Aid
Lack of Assurance of Sterility
Class II · Moderate risk
Rohto Cooling Eye Drops Dry Aid
Lack of Assurance of Sterility
Class II · Moderate risk
Rohto Cooling Eye Drops Digi Eye
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
Rohto Cooling Eye Drops ALL-IN-ONE
Lack of Assurance of Sterility
Class II · Moderate risk
BD ChloraPrep Clear
Lack of Assurance of Sterility: Affected product may exhibit an open or incomplete seal on the packaging of the applicator
Class II · Moderate risk
CLEVIPREX (clevidipine injectable emulsion)
Lack of Assurance of Sterility
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