Class I · High risk
Snowy Range Blue Alcohol Antiseptic 80% Topical Solution Hand…
Chemical Contamination: FDA analysis found the product to contain methanol, acetaldehyde, and acetal above the limits.
Class I drug recalls - the high-risk category
Class I is the FDA's most serious recall category: a reasonable probability that using the product will cause serious health consequences or death. It is a small share of all recalls, but the one to check first if a medication you take appears here.
1,750 recalls, newest first.
Class I · High risk
PrimeZEN Black 6000 capsule
Marketed Without An Approved NDA/ANDA: FDA analysis found the 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
Delsam Pharma's ARTIFICIAL TEARS
Non-Sterility: FDA analysis found unopened products to have bacterial contamination.
Class I · High risk
Artificial Tears
Non-Sterility: FDA analysis found unopened products to have bacterial contamination.
Class I · High risk
Easy Care First Aid 10 Person 2009 ANSI
Microbial Contamination of Non-Sterile Products: FDA Laboratory results found product to be contaminated with Bacillus lichenformis and Bacillus sonorensis.
Class I · High risk
CVS First Aid Home
Microbial Contamination of Non-Sterile Products: FDA Laboratory results found product to be contaminated with Bacillus lichenformis and Bacillus sonorensis.
Class I · High risk
Easy Care First Aid 25 Person 2009 ANSI
Microbial Contamination of Non-Sterile Products: FDA Laboratory results found product to be contaminated with Bacillus lichenformis and Bacillus sonorensis.
Class I · High risk
Easy Care First Aid Class A ANSI 25 Person
Microbial Contamination of Non-Sterile Products: FDA Laboratory results found product to be contaminated with Bacillus lichenformis and Bacillus sonorensis.
Class I · High risk
Easy Care First Aid 10 Person 2009 ANSI
Microbial Contamination of Non-Sterile Products: FDA Laboratory results found product to be contaminated with Bacillus lichenformis and Bacillus sonorensis.
Class I · High risk
Easy Care First Aid 25 Person 2009 ANSI
Microbial Contamination of Non-Sterile Products: FDA Laboratory results found product to be contaminated with Bacillus lichenformis and Bacillus sonorensis.
Class I · High risk
Adventure First Aid 1.5
Microbial Contamination of Non-Sterile Products: FDA Laboratory results found product to be contaminated with Bacillus lichenformis and Bacillus sonorensis.
Class I · High risk
Adventure First Aid 1.0
Microbial Contamination of Non-Sterile Products: FDA Laboratory results found product to be contaminated with Bacillus lichenformis and Bacillus sonorensis.
Class I · High risk
Adventure Marine 150
Microbial Contamination of Non-Sterile Products: FDA Laboratory results found product to be contaminated with Bacillus lichenformis and Bacillus sonorensis.
Class I · High risk
Easy Care first aid Burn Cream
Microbial Contamination of Non-Sterile Products: FDA Laboratory results found product to be contaminated with Bacillus lichenformis and Bacillus sonorensis.
Class I · High risk
Vancomycin Hydrochloride for Injection
Presence of Particulate Matter: Glass particulate matter detected in injectable.
Class I · High risk
Epinephrine
Discoloration: Product complaints of the repackaged Epinephrine API being discolored which could result in less effective product
Class I · High risk
Epinephrine
Discoloration: Product complaints of the repackaged Epinephrine API being discolored which could result in less effective product
Class I · High risk
Advil Liqui Gels
Labeling: Illegible Label; the adhesive migrated onto a portion of the label, causing it to tear when peeled back
Class I · High risk
Advil Liqui Gels
Labeling: Illegible Label; the adhesive migrated onto a portion of the label, causing it to tear when peeled back
Class I · High risk
Advil (ibuprofen)
Labeling: Illegible Label; the adhesive migrated onto a portion of the label, causing it to tear when peeled back
Class I · High risk
Iohexol (300 mg Iodine/mL)
Labeling: Label Error on Declared Strength: syringes mislabeled as 300 mg iodine/mL contained product 350 mg iodine/mL
Class I · High risk
Daptomycin for Injection 350 mg/vial 1 Single-dose vial
Labeling mixup: cartons labeled as Daptomycin 350 mg/vial were found to contain vials of Daptomycin 500 mg per vial
Class I · High risk
8.4% Sodium Bicarbonate Injection
Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration.
Class I · High risk
8.4% Sodium Bicarbonate Injection
Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration.
Class I · High risk
Adam's Polishes ALCOHOL BASED HAND SANITIZER
Chemical Contamination: FDA analysis found 1 lot of Adam's Polishes ALCOHOL BASED HAND SANITIZER isopropyl alcohol 75% v/v to contain methanol.