Class I · High risk Ongoing
Midazolam in 0.8% Sodium Chloride Injection 100 mg/100 mL
Reason Presence of Particulate Matter: Silicone
FDA Drug Recalls
17,898 recalls, newest first
Class I · High risk Ongoing
8.4% Sodium Bicarbonate Injection
Reason Presence of Particulate Matter: Silicone
Class II · Moderate risk Terminated
Integrity Biochem HSC 70-VA
Reason CGMP Deviation: Third party test results showing a presence of acetal and acetaldehyde at levels above USP specified amounts.
Class II · Moderate risk Terminated
Integrity Biochem HSC70-LV
Reason CGMP Deviation: Third party test results showing a presence of acetal and acetaldehyde at levels above USP specified amounts.
Class II · Moderate risk Terminated
Integrity Biochem HSC 70-LM
Reason CGMP Deviation: Third party test results showing a presence of acetal and acetaldehyde at levels above USP specified amounts.
Class I · High risk Terminated
Sucralfate Oral Suspension
Reason Microbial Contamination of Non-Sterile Products: identified as Bacillus cereus.
Class III · Low risk Terminated
Aminocaproic Acid Oral Solution
Reason Failed Excipient Specifications: high content of ethylene glycol (EG)
Class III · Low risk Ongoing
Synthroid
Reason Labeling: Wrong Barcode- One (1) of every forty (40) unit dose blister will contain incorrect barcode information that causes a 125mcg unit dose is scanned as 200mcg unit dose.
Class I · High risk Ongoing
The Rock
Reason Marketed Without an Approved NDA/ANDA: FDA analysis found the product to be tainted with Sildenafil an ingredient found in an FDA approved product for the treatment of male sexual enhancement, making this an unapproved drug.
Class II · Moderate risk Terminated
Montelukast Sodium Tablets
Reason Presence of Foreign Tablet(s)/Capsule(s): A foreign tablet was found in a bottle of Montelukast Sodium Tablets, USP 10mg, identified as metoprolol 25 mg.
Class II · Moderate risk Ongoing
Certain Over-The-Counter
Reason CGMP Deviations: OTC products were stored outside of labeled temperature requirements.
Class II · Moderate risk Terminated
Clinical TREAT Antifungal Powder
Reason CGMP deviations: the product was shipped from the Manufacturer to a Medline warehouse and released to stock while it was still under investigation for low assay results on the active ingredient miconazole nitrate.
Class III · Low risk Terminated
VANCOmycin HCI PF
Reason Labeling: Not Elsewhere Classified
Class III · Low risk Terminated
VANCOmycin HCI PF
Reason Labeling: Not Elsewhere Classified
Class III · Low risk Terminated
Oxytocin synthetic
Reason Labeling: Not Elsewhere Classified
Class III · Low risk Terminated
Bupropion Hydrochloride Extended-Release Tablets USP
Reason Failed Dissolution Specifications
Class III · Low risk Terminated
Epinephrine-Lidocaine HCl
Reason Subpotent: Failing Test Results for Epinephrine
Class I · High risk Terminated
2% Lidocaine HCl Injection
Reason Presence of Particulate Matter: identified as glass.
Class I · High risk Terminated
1% Lidocaine HCl Injection
Reason Presence of Particulate Matter: identified as glass.
Class I · High risk Terminated
4.2% Sodium Bicarbonate Injection
Reason Presence of Particulate Matter: identified as glass.
Class II · Moderate risk Terminated
Foscarnet Sodium 2.4mg/0.1 mL solution for injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Lidocaine HCL 2% and Oxymetazoline HCl 0.025% Solution for…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Tropi-Phen
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Lidocaine HCl 4% ophthalmic solution
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Calcium chloride Solution for Intravenous Injection
Reason Lack of Assurance of Sterility