Class I · High risk Ongoing
Brut Classic Antiperspirant & Deodorant
Reason Chemical contamination: Presence of benzene
FDA Drug Recalls
1,739 recalls · Class I, newest first
Class I · High risk Terminated
Hcg 6
Reason Non-sterility; bacterial contamination identified as Paenibacillus lautus.
Class I · High risk Terminated
RISE UP RED EDITION Capsules
Reason Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared tadalafil, an ingredient found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.
Class I · High risk Terminated
Avaphinal Maximum Male Enhancement Sexual Pills
Reason Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared sildenafil, an ingredient found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.
Class I · High risk Terminated
RED MAMMOTH capsules
Reason Marketed Without An Approved NDA/ANDA: Product was found to contain 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 Terminated
The Red Pill
Reason Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared tadalafil, an ingredient found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.
Class I · High risk Terminated
MAC DADDY PURPLE Capsules
Reason Marketed Without An Approved NDA/ANDA: product was found to contain undeclared tadalafil and/or sildenafil, ingredients found in FDA approved products for the treatment of male sexual enhancement, making these unapproved drugs.
Class I · High risk Terminated
MAC DADDY RED Capsules
Reason Marketed Without An Approved NDA/ANDA: product was found to contain undeclared tadalafil and/or sildenafil, ingredients found in FDA approved products for the treatment of male sexual enhancement, making these unapproved drugs.
Class I · High risk Terminated
Paragard T380a
Reason Non-sterility
Class I · High risk Terminated
MegMan Performance Booster
Reason Marketed Without An Approved NDA/ANDA: product was found to contain undeclared tadalafil, an ingredient found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.
Class I · High risk Terminated
Morphine Sulfate PF 25 mg/25mL
Reason Labeling: Label Mix up; A limited number of syringes containing HYDROmorphone HCl PF were incorrectly labeled as Morphine Sulfate PF with lot number 21104221A
Class I · High risk Terminated
HYDROmorphone HCl PF 10 mg/50 mL
Reason Labeling: Label Mix up; A limited number of syringes containing HYDROmorphone HCl PF were incorrectly labeled as Morphine Sulfate PF with lot number 21104221A
Class I · High risk Terminated
Hard Dawn
Reason Marketed Without an Approved NDA/ANDA: Firm was informed by Amazon that analytical testing showed the presence of tadalafil. Tadalafil is a FDA approved drug, making this product an unapproved drug.
Class I · High risk Terminated
Polymyxin B for Injection USP
Reason Presence of Particulate Matter; product complaint of hair discovered in a vial within the lot
Class I · High risk Terminated
Revitaderm Wound Care Gel
Reason Microbial Contamination of Non-sterile Product; FDA analysis found the product to be contaminated with Bacillus cereus.
Class I · High risk Terminated
Semglee
Reason Labeling: Missing Label: label missing from some Semglee prefilled pens.
Class I · High risk Terminated
SENNA Syrup
Reason Microbial Contamination of Non-Sterile Product
Class I · High risk Terminated
Clobetasol Propionate Ointment USP
Reason Microbial Contamination of Non-Sterile Products: presence of R. Pickettii bacteria
Class I · High risk Terminated
kleantouch HAND SANITIZER
Reason Marketed Without an Approved NDA/ANDA: Product labeled to contain methanol making it an unapproved new drug and contains methanol
Class I · High risk Terminated
Veklury
Reason Presence of Particulate Matter: investigation into a customer complaint confirmed the presence of glass particulates.
Class I · High risk Terminated
Klean Touch Hand Sanitizer
Reason Marketed Without an Approved NDA/ANDA: Product labeled to contain methanol making it an unapproved new drug and contains methanol
Class I · High risk Ongoing
Lidocaine Hydrochloride
Reason Superpotent Drug
Class I · High risk Terminated
Secret
Reason Chemical contamination: presence of benzene
Class I · High risk Terminated
Secret
Reason Chemical contamination: presence of benzene
Class I · High risk Terminated
Secret
Reason Chemical contamination: presence of benzene