Class I · High risk Ongoing
LEADER brand Lubricant Eye Drops
Reason Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
FDA Drug Recalls
1,739 recalls · Class I, newest first
Class I · High risk Ongoing
LEADER brand Lubricant Eye Drops
Reason Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
Class I · High risk Ongoing
LEADER brand Dry Eye Relief
Reason Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
Class I · High risk Ongoing
LEADER brand Eye Irritation Relief
Reason Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
Class I · High risk Terminated
Lubricating Tears Eye Drops
Reason Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
Class I · High risk Terminated
Polyvinyl Alcohol 1.4% Lubricating Eye Drops
Reason Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
Class I · High risk Terminated
Phenytoin Oral Suspension
Reason Failed Content Uniformity Specifications
Class I · High risk Ongoing
Kuka Flex Forte caplets
Reason Marketed Without an Approved NDA/ANDA: products found to contain undeclared diclofenac.
Class I · High risk Ongoing
Reumo Flex caplets
Reason Marketed Without an Approved NDA/ANDA: products found to contain undeclared diclofenac.
Class I · High risk Ongoing
Artri King Reforzado con Origa y Omega 3 tablets
Reason Marketed Without an Approved NDA/ANDA: products found to contain undeclared diclofenac.
Class I · High risk Ongoing
Elcys
Reason Presence of Particulate Matter: Silicone
Class I · High risk Ongoing
Midazolam in 0.8% Sodium Chloride Injection 100 mg/100 mL
Reason Presence of Particulate Matter: Silicone
Class I · High risk Ongoing
8.4% Sodium Bicarbonate Injection
Reason Presence of Particulate Matter: Silicone
Class I · High risk Terminated
Sucralfate Oral Suspension
Reason Microbial Contamination of Non-Sterile Products: identified as Bacillus cereus.
Class I · High risk Ongoing
The Rock
Reason Marketed Without an Approved NDA/ANDA: FDA analysis found the product to be tainted with Sildenafil an ingredient found in an FDA approved product for the treatment of male sexual enhancement, making this an unapproved drug.
Class I · High risk Terminated
2% Lidocaine HCl Injection
Reason Presence of Particulate Matter: identified as glass.
Class I · High risk Terminated
1% Lidocaine HCl Injection
Reason Presence of Particulate Matter: identified as glass.
Class I · High risk Terminated
4.2% Sodium Bicarbonate Injection
Reason Presence of Particulate Matter: identified as glass.
Class I · High risk Terminated
ION*Sinus Spray
Reason Microbial contamination of Non-Sterile Products
Class I · High risk Completed
Brexafemme
Reason Cross Contamination with Other Products: Potential cross-contamination of ibrexafungerp citrate drug substance with ezetimibe (a non-antibacterial beta-lactam compound).
Class I · High risk Terminated
Betaxolol Tablets
Reason Presence of Foreign Tablets/Capsules: There is a potential presence of oxycodone HCl tablets, USP 5 mg in bottles.
Class I · High risk Ongoing
SANDIMMUNE Oral Solution
Reason Crystallization: bottles of Sandimmune Oral Solution were determined to contain crystals.
Class I · High risk Ongoing
TheraBreath for Kids! Oral Rinse
Reason Microbial contamination of Non-Sterile Product; presence of yeast identified as Candida parapsilosis
Class I · High risk Ongoing
Dr. Berne's MSM DROPS 5% Solution
Reason Non-Sterility
Class I · High risk Terminated
WEFUN Capsules 825 mg
Reason Marketed Without an Approved NDA/ANDA: FDA analysis found the product to be tainted with sildenafil, an ingredient found in a FDA approved product for the treatment of male sexual enhancement, making this an unapproved drug.