Class I · High risk
Acetaminophen Injection
Labeling: Label Mix-up: a bag of Dexmedetomidine HCl in 0.9% Sodium Chloride Injection was found inside an overwrap labeled Acetaminophen Injection 1,000 mg per 100 mL (10 mg/mL)
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
Potassium Chloride Extended-Release Capsules
Failed Dissolution Specifications
Class I · High risk
Acetaminophen Extra Strength Tablets
Labeling: Label Mix-Up: Some bottles of Acetaminophen Extra Strength 500 mg tablets were incorrectly labeled with the drug facts label for Aspirin 81 mg tablets.
Class I · High risk
STELLALIFE VEGA Oral Care
Microbial Contamination of Non-Sterile Products: multiple Bacillus species organisms
Class I · High risk
Potassium Chloride Extended-Release Capsules
Failed Dissolution Specifications
Class I · High risk
Potassium Chloride Extended-Release Capsules
Failed Dissolution Specifications
Class I · High risk
Docetaxel Injection
Presence of Particulate Matter: Presence of particulate matter from the stopper in the drug product.
Class I · High risk
Docetaxel Injection
Presence of Particulate Matter: Presence of particulate matter from the stopper in the drug product.
Class I · High risk
suntegrity
Microbial Contamination of Non-Sterile Products: Presence of Aspergillus Sydowii (Mold)
Class I · High risk
Phenylephrine in 0.9% Sodium Chloride Injection Preservative Free
Labeling: Label mix-up - ephedrine syringes mislabeled as phenylephrine.
Class I · High risk
Schwinnng Herbal Dietary Supplement Capsules
Marketed Without An Approved NDA/ANDA
Class I · High risk
Tirzepatide 10 mg/0.5 mL Sterile Solution
Labeling: Label Mix-up - product labeled as tirzepatide contains testosterone cypionate
Class I · High risk
Sapropterin Dihydrochloride Powder for Oral Solution 100mg
Sub-potent Drug; powder discoloration associated with decreased potency
Class I · High risk
Javygtor (sapropterin dihydrochloride)
Sub-potent Drug; powder discoloration associated with decreased potency
Class I · High risk
Atovaquone Oral Suspension USP
Microbial contamination of a non-sterile product: potential Bacillus cereus contamination.
Class I · High risk
Aruba Aloe Hand Sanitizer Gel
Chemical Contamination: Product manufactured with ethanol API that contains methanol
Class I · High risk
Alcoholada Gel
Chemical Contamination: Product manufactured with ethanol API that contains methanol
Class I · High risk
Vancomycin Hydrochloride for Oral Solution
Superpotent Drug: Due to overfilling of drug powder
Class I · High risk
Honey Manuka Bunny Love
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
Class I · High risk
Alphastrip Male Performance Enhancer
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
Class I · High risk
The GOAT SUBLINGUAL STRIP
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
Class I · High risk
Silverback Xxx Power Male Enhancement
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
Class I · High risk
libigrow RED DRAGON+
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
Class I · High risk
GoHARD 25000
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
Class I · High risk
Pink Pussycat Honey
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.