Class I · High risk Ongoing
LUBRICANT EYE DROPS (Carboxymethylcellulose Sodium 0.5%), packaged 0.5 FL OZ (15mL) bottles (Twin Pack), Distributed by: Rite Aid…
Reason Non-Sterility
FDA Drug Recalls
17,898 recalls, newest first
Class I · High risk Ongoing
EQUATE brand Hydration PF Lubricant Eye Drops (Polyethylene glycol 400 0.4% and Propylene glycol 0.3%) packaged in 0.34 FL OZ (10…
Reason Non-Sterility
Class I · High risk Ongoing
Velocity Pharma brand Lubricating Eye Drop (Propylene glycol Eye Drops 0.6%), packaged in 3 bottles of 0.33 FL OZ (10 mL) each…
Reason Non-Sterility
Class I · High risk Ongoing
Leader brand Lubricant Eye Drops (Propylene glycol Eye Drops 0.6%), packaged in 0.33 FL OZ (10 mL) bottles, Cardinal Health…
Reason Non-Sterility
Class I · High risk Ongoing
Target brand High Performance Lubricant Eye Drops (Polyethylene glycol 400 0.4%, Propylene glycol 0.3%) a) 0.5 FL OZ (15mL)…
Reason Non-Sterility
Class I · High risk Ongoing
Leader brand Dry Eye Relief (Carboxymethylcellulose Sodium 1%), packaged in 0.5 FL OZ (15 mL) bottles, Cardinal Health Dublin…
Reason Non-Sterility
Class I · High risk Ongoing
CVS Health brand, Lubricant Gel Drops (Carboxymethylcellulose Sodium 1%) packaged in a) 0.5 FL OZ (15mL) bottles (Single Pack)…
Reason Non-Sterility
Class I · High risk Ongoing
Leader brand Eye Irritation Relief (Polyvinyl alcohol 0.5%, Povidone 0.6%, Tetrahydrozoline 0.05%), packaged in 0.5 FL OZ (15 mL)…
Reason Non-Sterility
Class I · High risk Ongoing
CVS brand Multi Action Relief Drops (Polyvinyl alcohol 0.5%, Povidone 0.6%, Tetrahydrozoline 0.05%) packaged in 0.5 FL OZ (15mL)…
Reason Non-Sterility
Class I · High risk Ongoing
Leader brand Dry Eye Relief (Polyethylene glycol 400 0.4% and Propylene glycol 0.3%) packaged in 0.33 FL OZ (10 mL) bottles…
Reason Non-Sterility
Class I · High risk Ongoing
CVS Health brand Lubricating Gel Drops (Polyethylene glycol 400 0.4% and Propylene glycol 0.3%), packaged in 0.33 FL OZ (10 mL)…
Reason Non-Sterility
Class I · High risk Ongoing
Rugby brand Polyvinyl Alcohol 1.4% Lubricating Eye Drops, packaged in 0.5 FL OZ (15 mL) bottles, Distributed by: Rugby…
Reason Non-Sterility
Class I · High risk Ongoing
CVS Health brand Lubricant Eye Drops (Propylene glycol 0.6%), packaged in a) 0.33 FL OZ (10mL) bottles (Single Pack) (NDC…
Reason Non-Sterility
Class I · High risk Ongoing
Leader brand Lubricant Eye Drops (Carboxymethylcellulose Sodium 0.5%), packaged in a) 0.5 FL OZ (15mL) bottles (Single Pack)…
Reason Non-Sterility
Class I · High risk Ongoing
CVS Health brand Lubricant Eye Drops (Carboxymethylcellulose Sodium 0.5%), packaged in a) 0.5 FL OZ (15mL) bottles (Single Pack)…
Reason Non-Sterility
Class II · Moderate risk Ongoing
KinderMed INFANTS' PAIN & FEVER Acetaminophen, 160 mg per 5 mL bottles, Oral Suspension, Organic Cherry Flavor, 2 FL OZ (59 mL)…
Reason Failed Impurities/Degradation Specifications
Class II · Moderate risk Ongoing
KinderMed KIDS' PAIN & FEVER Acetaminophen, 160 mg per 5 mL bottles, Oral Suspension, Organic Cherry Flavor, 4 FL OZ (118 mL)…
Reason Failed Impurities/Degradation Specifications
Class II · Moderate risk Terminated
PAROXETINE tablets, USP, 40 mg, Packaged as a) 30-count bottle, NDC 60429-737-30; b) 90-count bottle NDC 60429-737-90…
Reason Failed Impurities/Degradation Specifications-Manufacturer Apotex Inc. recalling lots due to Out of specification results for the excipient Amadori…
Class II · Moderate risk Terminated
PAROXETINE tablets, USP, 20 mg, Packaged as a) 90-count bottle NDC 60429-735-90; b)1000-count bottle, NDC 60429-735-10; Rx Only…
Reason Failed Impurities/Degradation Specifications-Manufacturer Apotex Inc. recalling lots due to Out of specification results for the excipient Amadori…
Class II · Moderate risk Terminated
PAROXETINE tablets, USP, 10 mg, Packaged as a) 30-count bottle, NDC 60429-734-30; b) 90-count bottle NDC 60429-734-90…
Reason Failed Impurities/Degradation Specifications-Manufacturer Apotex Inc. recalling lots due to Out of specification results for the excipient Amadori…
Class III · Low risk Terminated
Testosterone Gel, 1.62% CIII (Alcohol 80% v/v), packaged in 30 unit-dose packets per carton, Rx only, Teva Pharmaceuticals USA…
Reason OOS for viscosity
Class III · Low risk Ongoing
Tropicamide 1% (10mg/mL), Cyclopentolate 1% (10mg/mL), Phenylephrine 2.5% (25mg/mL), Ketorolac 0.5% (5mg/mL), 5 mL bottles, For…
Reason Labeling: Label Mix-Up: The label of a dropper bottle mistakenly states the container is a 0.5mL single-use syringe instead of a 5 mL dropper
Class II · Moderate risk Terminated
VANCOMYCIN 1.25 g added to 0.9% Sodium Chloride 250 mL Injection, 250 mL bag, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
SUCcinylcholine Chloride 100 mg/5mL Injection (Concentration = 20mg/mL), 5 mL fill 6 mL Syringe, Rx only, Repackaged by SCA…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
SUCcinylcholine Chloride 200 mg/10mL Injection (Concentration = 20mg/mL), 10 mL fill 12 mL Syringe, Rx only, Repackaged by SCA…
Reason Lack of Assurance of Sterility