Class I · High risk Ongoing
Leader brand Lubricant Eye Drops
Reason Non-Sterility
FDA Drug Recalls
220 recalls · Class I, newest first
Class I · High risk Ongoing
CVS Health brand Lubricant Eye Drops
Reason Non-Sterility
Class I · High risk Ongoing
Dr. Ergin's SugarMD
Reason MARKETED WITHOUT AN APPROVED NDA/ANDA: Product found to be tainted with metformin and glyburide
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 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 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 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 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 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 Ongoing
Vegetal Vigra
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.
Class I · High risk Ongoing
DYNAMITE SUPER capsule
Reason Marketed without an Approved NDA/ANDA: FDA analysis found product to be tainted with undeclared sildenafil and tadalafil, ingredients found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.
Class I · High risk Ongoing
NUX Male Enhancement capsule
Reason Marketed without an Approved NDA/ANDA: FDA analysis found product to be tainted with undeclared sildenafil and tadalafil, ingredients found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.
Class I · High risk Ongoing
Pro Power Knight Plus capsule
Reason Marketed without an Approved NDA/ANDA: FDA analysis found product to be tainted with undeclared sildenafil and tadalafil, ingredients found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.
Class I · High risk Ongoing
Atovaquone Oral Suspension USP
Reason Microbial Contamination of Non-Sterile Product: Objectionable organism, identified as Bacillus cereus, found in product during testing of repackaged product.
Class I · High risk Ongoing
Delsam Pharma's Artificial Eye Ointment
Reason Non-Sterility: FDA analysis found unopened tubes to be contaminated with bacteria.