Class I · High risk
Limar Hand Sanitizer
Labeling Not Elsewhere Classified: Hand sanitizer packaged in containers resembling drinking water bottles.
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
Prairie Wolf Distillery Alcohol Antiseptic 80%
Hand sanitizer packaged in bottles that resemble beverage containers.
Class I · High risk
Topotecan Injection 4 mg/4mL
Presence of Particulate Matter: Complaint received of a glass particle observed inside the vial. The vial was returned to Teva for further analysis where two other particulates were found and identified as one (1) grey silicone particle and one (1) translucent, colorless cotton fiber.
Class I · High risk
maXXzen Platinum 12000 capsule
Marketed without an approved NDA/ANDA - Product found to be tainted with Sildenafil and Tadalafil.
Class I · High risk
PremierZEN Platinum 8000 capsule
Marketed without an approved NDA/ANDA - Product found to be tainted with Sildenafil and Tadalafil.
Class I · High risk
PremierZEN Gold 7000 capsule
Marketed without an approved NDA/ANDA - Product found to be tainted with Sildenafil and Tadalafil.
Class I · High risk
MEDICALLY MINDED Hand Sanitizer Gel
Chemical Contamination: FDA analysis found 1 lot of MEDICALLY MINDED Hand Sanitizer Gel, ANTIMICROBIAL FORMULA (ethyl alcohol 70%) to be below the label claim for ethanol content and to contain methanol.
Class I · High risk
MEDICALLY MINDED Hand Sanitizer Gel
Chemical Contamination: FDA analysis found 1 lot of MEDICALLY MINDED Hand Sanitizer Gel, ANTIMICROBIAL FORMULA (ethyl alcohol 70%) to be below the label claim for ethanol content and to contain methanol.
Class I · High risk
C-Progesterone Oil 100 Mg/Ml
Non-Sterility
Class I · High risk
Poseidon Platinum 3500 capsule
Marketed Without An Approved NDA/ANDA: Product found to contain undeclared sildenafil and tadalafil making them unapproved drugs for which the safety and efficacy have not been established and therefore subject to recall.
Class I · High risk
DiBAR LABS Hand Sanitizer
Chemical Contamination: FDA analysis found 3 lots of DiBAR hand Sanitizer to be below the label claim for ethanol content and to contain methanol.
Class I · High risk
1% Lidocaine HCl Injection
Labeling: Label Mix-Up: some vials labeled to contain 0.5% Bupivacaine Hydrochloride Injection, USP may contain 1% Lidocaine HCl Injection, USP and some vials labeled to contain 1% Lidocaine HCl Injection, USP may contain 0.5% Bupivacaine Hydrochloride Injection, USP
Class I · High risk
0.5% Bupivacaine Hydrochloride Injection
Labeling: Label Mix-Up: some vials labeled to contain 0.5% Bupivacaine Hydrochloride Injection, USP may contain 1% Lidocaine HCl Injection, USP and some vials labeled to contain 1% Lidocaine HCl Injection, USP may contain 0.5% Bupivacaine Hydrochloride Injection, USP
Class I · High risk
NP Thyroid 120 Thyroid Tablets
Subpotent Drug
Class I · High risk
NP Thyroid 90 Thyroid Tablets
Subpotent Drug
Class I · High risk
NP Thyroid 60 Thyroid Tablets
Subpotent Drug
Class I · High risk
NP Thyroid 30 Thyroid Tablets
Subpotent Drug
Class I · High risk
NP Thyroid 15 Thyroid Tablets
Subpotent Drug
Class I · High risk
Coconut Stand CoCo TKO Hand Sanitizer
Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde.
Class I · High risk
Goose Creek Hand Sanitizer aloe Tropical Daydream
Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde.
Class I · High risk
Goose Creek Hand Sanitizer aloe Watermelon Lemonade
Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde.
Class I · High risk
Goose Creek Hand Sanitizer aloe Red
Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde.
Class I · High risk
Goose Creek Hand Sanitizer aloe Optimistic Vibes
Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde.
Class I · High risk
Goose Creek Hand Sanitizer aloe Melon Picnic
Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde.
Class I · High risk
Goose Creek Hand Sanitizer aloe Marshmallows
Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde.