Class III · Low risk
Clotrimazole and Betamethasone Dipropionate Cream USP
Failed Content Uniformity Specifications: Out-of-specification result for the Betamethasone Dipropionate assay of a stability sample
FDA Drug Recalls
1,018 recalls, newest first
Class II · Moderate risk
0.9% Sodium Chloride Injection USP
Lack of sterility assurance: leaking bags
Class II · Moderate risk
hydrALAZINE HCl Tablets
Failed Impurities/Degradation Specifications: Out of specification result obtained during routine stability testing for Impurities.
Class II · Moderate risk
Oxycodone Hydrochloride Oral Solution
Impurity failure at 0-time of the repackaged lot.
Class II · Moderate risk
Alprazolam Tablets
CGMP deviations
Class II · Moderate risk
Dexamethasone Elixir
Failed Impurities/Degradation Specifications: higher than permissible levels of unknown impurities were found in the drug product.
Class III · Low risk
Sapropterin Dihydrochloride Powder for Oral Solution
Subpotent Drug: Out-of-specification results observed in Assay in sapropterin dihydrochloride powder 100mg.
Class II · Moderate risk
Moxifloxacin Ophthalmic Solution USP 0.5%
Failed impurities/degradation specifications
Class II · Moderate risk
Olanzapine Tablets
cGmp Deviations
Class II · Moderate risk
Amlodipine and Olmesartan Medoxomil Tablets
cGMP deviations
Class II · Moderate risk
Pyrazinamide Tablets
cGMP Deviations
Class II · Moderate risk
Alprazolam Tablets
cGMP Deviations
Class II · Moderate risk
Alprazolam Tablets
cGMP Deviations
Class II · Moderate risk
Alprazolam Tablets
cGMP Deviations
Class II · Moderate risk
Alprazolam Tablets
cGMP Deviations
Class III · Low risk
Norepinephrine bitartrate 16 mg in 250 mL NaCl 0.9%
Subpotent drug
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 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.