Class I · High risk
Revitaderm Wound Care Gel
Microbial Contamination of Non-sterile Product; FDA analysis found the product to be contaminated with Bacillus cereus.
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
Semglee (insulin glargine)
Labeling: Missing Label: label missing from some Semglee prefilled pens.
Class I · High risk
SENNA Syrup
Microbial Contamination of Non-Sterile Product
Class I · High risk
Clobetasol Propionate Ointment USP
Microbial Contamination of Non-Sterile Products: presence of R. Pickettii bacteria
Class I · High risk
kleantouch HAND SANITIZER
Marketed Without an Approved NDA/ANDA: Product labeled to contain methanol making it an unapproved new drug and contains methanol
Class I · High risk
Veklury (remdesivir)
Presence of Particulate Matter: investigation into a customer complaint confirmed the presence of glass particulates.
Class I · High risk
Klean Touch Hand Sanitizer
Marketed Without an Approved NDA/ANDA: Product labeled to contain methanol making it an unapproved new drug and contains methanol
Class I · High risk
Lidocaine Hydrochloride
Superpotent Drug
Class I · High risk
Secret
Chemical contamination: presence of benzene
Class I · High risk
Secret
Chemical contamination: presence of benzene
Class I · High risk
Secret
Chemical contamination: presence of benzene
Class I · High risk
Secret
Chemical contamination: presence of benzene
Class I · High risk
Old Spice
Chemical contamination: presence of benzene
Class I · High risk
Old Spice
Chemical contamination: presence of benzene
Class I · High risk
Old Spice
Chemical contamination: presence of benzene
Class I · High risk
AmericanScreening HAND SANITIZER
Labeling Not Elsewhere Classified: Hand sanitizer packaged in containers resembling drinking water bottles.
Class I · High risk
Enoxaparin Sodium Injection
Temperature Abuse; temperature excursion during shipping
Class I · High risk
Odor-Eaters Spray Powder
Chemical contamination: Presence of benzene
Class I · High risk
artnaturals hand sanitizer
Chemical Contamination: presence of benzene, acetaldehyde, and acetal.
Class I · High risk
Cubicin (daptomycin for injection)
Presence of Particulate Matter: Identified as Glass Particles
Class I · High risk
Lidocaine Hydrochloride Topical Solution USP 4%
Superpotent Drug
Class I · High risk
Methocarbamol 500mg Tablet
Labeling: Label Error on Declared Strength; Bottles labeled as Methocarbamol 500 mg Tablets actually contain Methocarbamol 750 mg Tablets
Class I · High risk
Tinactin (Tolnaftate 1%)
Chemical Contamination: presence of benzene
Class I · High risk
Tinactin (Tolnaftate 1%)
Chemical Contamination: presence of benzene
Class I · High risk
Tinactin (Tolnaftate 1%)
Chemical Contamination: presence of benzene