Class I · High risk
Hcg 6
Non-sterility; bacterial contamination identified as Paenibacillus lautus.
FDA Drug Recalls
14,806 recalls, newest first
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 II · Moderate risk
Diazepam Oral Solution
Failed Impurities/Degradation Specifications: Out of specification results for related substances.
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 II · Moderate risk
Erythromycin Topical Gel USP
Failed Impurities/Degradation Specifications: Lot not meeting specification for Unknown Max Related Compounds.
Class II · Moderate risk
Chlorthalidone Tablets USP 25 mg
Foreign Matter identified as stainless steel microscopic wear particles mixed with punch lubricant oil and silicone particles from the dust cup
Class I · High risk
Paragard T380a
Non-sterility
Class II · Moderate risk
Prevantics
cGMP deviations: uncertainty of the adequacy of the validation of the test methods used to manufacture the products.
Class II · Moderate risk
Prevantics
cGMP deviations: uncertainty of the adequacy of the validation of the test methods used to manufacture the products.
Class II · Moderate risk
Prevantics
cGMP deviations: uncertainty of the adequacy of the validation of the test methods used to manufacture the products.
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 II · Moderate risk
Cystex Tablet
CGMP Deviations
Class II · Moderate risk
DBI Magnums Tablet
CGMP Deviations
Class II · Moderate risk
Coated Back Relief Tablet
CGMP Deviations
Class II · Moderate risk
Legatrin (Acetaminophen 500 mg, Diphenhydramine HCl 50 mg)
CGMP Deviations
Class II · Moderate risk
Back Relief II
CGMP Deviations
Class II · Moderate risk
Pain Aid PMF Caplet
CGMP Deviations