Class I · High risk
SYMJEPI (epinephrine injection, USP)
Defective Delivery System: Potential clogging of the needle preventing the dispensing of epinephrine.
FDA Drug Recalls
98 recalls · Class I, newest first
Class I · High risk
Meclizine Hydrochloride Tablets USP
Labeling: Label mix-up: Incorrect label placed on product. Shipper cases labeled Meclizine Hydrochloride Tablets contain bottles incorrectly labeled as PredniSONE Tablets. The tablets in the bottles are Meclizine Hydrochloride
Class I · High risk
SyrSpend SF Suspending Base
Microbial Contamination of Non-Sterile Product: Product is contaminated with Burkholderia gladioli.
Class I · High risk
Sodium Acetate Injection
Presence of particulate matter: particulates composed of carbon and oxygen with varying amounts of iron and trace amounts of sodium, silicon, chromium, aluminum and cellulose.
Class I · High risk
HAND SANITIZER Isopropyl Alcohol Antiseptic 75%
Chemical Contamination: FDA analysis found 1 lot of HAND SANITIZER Isopropyl Alcohol Antiseptic 75%, to contain methanol.
Class I · High risk
Sure Regular Antiperspirant Deodorant Aerosol
Chemical contamination: Presence of benzene
Class I · High risk
Sure Unscented Anti-perspirant Deodorant Aerosol
Chemical contamination: Presence of benzene
Class I · High risk
Brut Classic Antiperspirant & Deodorant
Chemical contamination: Presence of benzene
Class I · High risk
Hcg 6
Non-sterility; bacterial contamination identified as Paenibacillus lautus.
Class I · High risk
RISE UP RED EDITION Capsules
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
Avaphinal Maximum Male Enhancement Sexual Pills
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
RED MAMMOTH capsules
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
The Red Pill
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
MAC DADDY PURPLE Capsules
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
MAC DADDY RED Capsules
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
Paragard T380a
Non-sterility
Class I · High risk
MegMan Performance Booster
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
Morphine Sulfate PF 25 mg/25mL
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
HYDROmorphone HCl PF 10 mg/50 mL
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
Hard Dawn
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
Polymyxin B for Injection USP
Presence of Particulate Matter; product complaint of hair discovered in a vial within the lot
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 · High risk
Semglee (insulin glargine)
Labeling: Missing Label: label missing from some Semglee prefilled pens.