Class II · Moderate risk
Lactulose Solution
Microbial contamination of non-sterile product: product failed Total Yeast/Mold Count specification.
FDA Drug Recalls
18,003 recalls, newest first
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
Class II · Moderate risk
Latanoprost PF Solution
Incorrect/Undeclared Excipient; non-pharmaceutical grade PEG 40 Castor Oil was used due to a mislabeling by the supplier
Class II · Moderate risk
Curcumin Emulsion 10mg/ml Injection
Incorrect/Undeclared Excipient; non-pharmaceutical grade PEG 40 Castor Oil was used due to a mislabeling by the supplier
Class III · Low risk
Paroxetine Extended-Release Tablets USP
Failed Dissolution Specifications: out of specification observed in dissolution testing at 3 month long term stability study.
Class II · Moderate risk
Potassium Phosphate
Lack of Assurance of Sterility
Class II · Moderate risk
Potassium Phosphate
Lack of Assurance of Sterility
Class II · Moderate risk
Potassium Phosphate
Lack of Assurance of Sterility
Class II · Moderate risk
QUELICIN (Succinylcholine Chloride)
Lack of Assurance of Sterility
Class I · High risk
MAN OF STEEL capsules
Marketed Without An Approved NDA/ANDA: FDA analysis found this product to contain undeclared sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making this an unapproved drug for which safety and efficacy have not been established and therefore, subject to recall.
Class II · Moderate risk
Potassium PHOSphate added to 0.9% Sodium Chloride 250 mL Bag 30 mMol
Lack of sterility assurance