Class II · Moderate risk
0.9% Sodium Chloride Injection USP
Lack of Assurance of Sterility: Customer complaints for leaking bags.
FDA Drug Recalls
14,806 recalls, newest first
Class I · High risk
D-ZINE Rapid Size and Strength capsules
Marketed Without An Approved NDA/ANDA: Product contains Methylstenbolone or Dymethazine.
Class I · High risk
ULTRA-STEN Rapid Size and Strength capsules
Marketed Without An Approved NDA/ANDA: Product contains Methylstenbolone or Dymethazine.
Class II · Moderate risk
Carbamazepine Oral Suspension
Labeling Error: Label mix-up. Products' unit dose cups are correctly labeled, but the product carton lists incorrect volume and NDC.
Class III · Low risk
Buprenorphine and Naloxone Sublingual Tablets 8 mg/2 mg 30 tablets per Bottle
Failed Impurities/Degradation Specifications: out of specification test results for related compounds largest unknown impurity.
Class III · Low risk
Buprenorphine and Naloxone Sublingual Tablets
Failed Impurities/Degradation Specifications: out of specification test results for related compounds largest unknown impurity.
Class III · Low risk
Obagi-C Rx System C-Therapy Night Cream
Labeling: Incorrect or Missing Package Insert - Obagi-C Rx System C-Therapy Night Cream is being recalled due to incomplete packaging/labeling. The bottle is missing the product insert and outer carton which contain the complete instruction for use and safety information.
Class II · Moderate risk
parodontax WHITENING
Presence of Foreign Substance: possibility of the presence of metal in the product.
Class II · Moderate risk
Lactulose Solution
Microbial contamination of non-sterile product: product failed Total Yeast/Mold Count specification.
Class II · Moderate risk
Lactulose Solution
Microbial contamination of non-sterile product: product failed Total Yeast/Mold Count specification.
Class II · Moderate risk
Potassium PHOSphate in 5% Dextrose Injection
Lack of Assurance of Sterility; media fill failure at manufacturer
Class II · Moderate risk
Potassium PHOSphate in 0.9% Sodium Chloride Injection
Lack of Assurance of Sterility; media fill failure at manufacturer
Class II · Moderate risk
Potassium PHOSphate in 5% Dextrose Injection
Lack of Assurance of Sterility; media fill failure at manufacturer
Class II · Moderate risk
Potassium PHOSphate in 0.9% Sodium Chloride Injection
Lack of Assurance of Sterility; media fill failure at manufacturer
Class II · Moderate risk
Potassium PHOSphate in 5% Dextrose Injection
Lack of Assurance of Sterility; media fill failure at manufacturer
Class II · Moderate risk
Potassium PHOSphate in 0.9% Sodium Chloride Injection
Lack of Assurance of Sterility; media fill failure at manufacturer
Class II · Moderate risk
Potassium PHOSphate in 0.9% Sodium Chloride Injection
Lack of Assurance of Sterility; media fill failure at manufacturer
Class II · Moderate risk
Potassium PHOSphate in 0.9% Sodium Chloride Injection
Lack of Assurance of Sterility; media fill failure at manufacturer
Class II · Moderate risk
Potassium PHOSphate in 5% Dextrose Injection
Lack of Assurance of Sterility; media fill failure at manufacturer
Class II · Moderate risk
Potassium PHOSphate in 0.9% Sodium Chloride Injection 20 mMol in…
Lack of Assurance of Sterility; media fill failure at manufacturer
Class II · Moderate risk
Potassium PHOSphate in 0.9% Sodium Chloride Injection 15 mMol in…
Lack of Assurance of Sterility; media fill failure at manufacturer
Class II · Moderate risk
Potassium PHOSphate in 0.9% Sodium Chloride Injection
Lack of Assurance of Sterility; media fill failure at manufacturer
Class II · Moderate risk
Succinylcholine Chloride Injection
Lack of Assurance of Sterility; media fill failure at manufacturer
Class II · Moderate risk
Timolol-Brimonidine-Dorzolamide-Latanoprost
Incorrect/Undeclared Excipient; non-pharmaceutical grade PEG 40 Castor Oil was used due to a mislabeling by the supplier
Class II · Moderate risk
Timolol-Latanoprost PF Solution
Incorrect/Undeclared Excipient; non-pharmaceutical grade PEG 40 Castor Oil was used due to a mislabeling by the supplier