Class I · High risk
Cord Care POWDER
Microbial Contamination of a Non-Sterile Product: Product tested positive for Cronobacter Sakazakii.
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
Happy Ducts Compress
Microbial Contamination of a Non-Sterile Product: Product tested positive for Cronobacter Sakazakii.
Class I · High risk
NP Thyroid 120
Subpotent Drug: FDA analysis found these products to be less than the labeled claim for the levothyroxine (T4) portion of the product.
Class I · High risk
NP Thyroid 15
Subpotent Drug: FDA analysis found these products to be less than the labeled claim for the levothyroxine (T4) portion of the product.
Class I · High risk
M Hand Sanitizer Ethyl Alcohol Antiseptic 80%v/v
Chemical Contamination and Subpotent Drug: FDA analysis found product to contain methanol and below label claim for ethanol.
Class I · High risk
Leafree Instant Hand Sanitizer Aloe Vera
Marketed without an Approved NDA/ANDA; product labeled as Edible Alcohol rendering the product an unapproved new drug and misbranded.
Class I · High risk
Red-E Tablet
Marketed Without An Approved NDA/ANDA: product found to be tainted with sildenafil, an FDA approved drug for the treatment of male erectile dysfunction, making this an unapproved drug fro which the safety and efficacy have not been established and therefore subject to recall.
Class I · High risk
Nature Throid
Subpotent Drug: FDA analysis found product to be subpotent
Class I · High risk
Nature Throid
Subpotent Drug: FDA analysis found product to be subpotent
Class I · High risk
Nature Throid
Subpotent Drug: FDA analysis found product to be subpotent
Class I · High risk
Nature Throid
Subpotent Drug: FDA analysis found product to be subpotent
Class I · High risk
Nature Throid
Subpotent Drug: FDA analysis found product to be subpotent
Class I · High risk
WP Thyroid
Subpotent Drug: FDA analysis found product to be subpotent
Class I · High risk
Goldenseal Root Powder Organic
Microbial Contamination of Non-Sterile Products: FDA laboratory analysis found product to be contaminated with various microorganisms including Enterobacter cloacae, Cronobacter sakazakii, Cronobacter dublinensis, among others.
Class I · High risk
Tranexamic Acid Injection
Labeling: Label Mix-Up; potential for cartons labeled as Tranexamic Acid Injection, USP to contain vials of Amiodarone HCl Injection, USP and cartons labeled as Amiodarone HCl Injection, USP to contain vials of Tranexamic Acid Injection, USP.
Class I · High risk
Amiodarone Hydrochloride Injection
Labeling: Label Mix-Up; potential for cartons labeled as Tranexamic Acid Injection, USP to contain vials of Amiodarone HCl Injection, USP and cartons labeled as Amiodarone HCl Injection, USP to contain vials of Tranexamic Acid Injection, USP.
Class I · High risk
Skin Guard 24 All-Day Hand Sanitizer 1 4"x6" Hand Sanitizing…
Marketed without an Approved NDA/ANDA; product labeled to contain 0.56% methanol making it an unapproved new drug
Class I · High risk
Skin Guard 24 All-Day Hand Sanitizer 10 mL Pocket Pen Dist by: SG24 LLC
Marketed without an Approved NDA/ANDA; product labeled to contain 0.56% methanol making it an unapproved new drug
Class I · High risk
SkinGuard 24 All-Day Hand Sanitizer 8 oz. bottle with foam pump
Marketed without an Approved NDA/ANDA; product labeled to contain 0.56% methanol making it an unapproved new drug
Class I · High risk
SkinGuard 24 All-Day Hand Sanitizer 2.67 oz. bottle with foam pump
Marketed without an Approved NDA/ANDA; product labeled to contain 0.56% methanol making it an unapproved new drug
Class I · High risk
Florance Morris ANTISEPTIC Hand Sanitizer
Chemical Contamination: FDA analysis found the product contains methanol, additionally it is sub-potent for ethanol content.
Class I · High risk
Volu-Sol Handrub Sanitizing Solution
Marketed Without an Approved NDA/ANDA: product lists methanol as an inactive ingredient on the label.
Class I · High risk
Incredible Products Gelbac T Antibacterial Hand Gel
Chemical Contamination: Product contains methanol as an active ingredient and is sub-potent for ethanol.
Class I · High risk
Heparin Sodium 10
Cross Contamination with Other Product(s): containers labeled as having methylparaben and propylparaben as preservatives, actually contained undeclared benzyl alcohol and did not contain any parabens.
Class I · High risk
Heparin Sodium 5
Cross Contamination with Other Product(s): containers labeled as having methylparaben and propylparaben as preservatives, actually contained undeclared benzyl alcohol and did not contain any parabens.