Class III · Low risk
Opium Tincture
Subpotent Drug
FDA Drug Recalls
18,003 recalls, newest first
Class II · Moderate risk
Oxybutynin Chloride Extended-Release Tablet USP
Failed Dissolution Specifications-out-of-specification (OOS) test results observed for dissolution at the 6 month long term time point.
Class II · Moderate risk
Oxybutynin Chloride Extended-Release Tablet USP
Failed Dissolution Specifications-out-of-specification (OOS) test results observed for dissolution at the 6 month long term time point.
Class II · Moderate risk
Oxybutynin Chloride Extended-Release Tablet USP
Failed Dissolution Specifications-out-of-specification (OOS) test results observed for dissolution at the 6 month long term time point.
Class II · Moderate risk
Strong Iodine Solution U.S.P.
CGMP Deviations: Recall due to the absence of USP CGMP compendial requirements.
Class I · High risk
ELCYS (cysteine hydrochloride injection)
Presence of Particulate Matter: Silicone
Class I · High risk
Midazolam in 0.8% Sodium Chloride Injection 100 mg/100 mL
Presence of Particulate Matter: Silicone
Class I · High risk
8.4% Sodium Bicarbonate Injection
Presence of Particulate Matter: Silicone
Class II · Moderate risk
Integrity Biochem HSC 70-VA
CGMP Deviation: Third party test results showing a presence of acetal and acetaldehyde at levels above USP specified amounts.
Class II · Moderate risk
Integrity Biochem HSC70-LV
CGMP Deviation: Third party test results showing a presence of acetal and acetaldehyde at levels above USP specified amounts.
Class II · Moderate risk
Integrity Biochem HSC 70-LM
CGMP Deviation: Third party test results showing a presence of acetal and acetaldehyde at levels above USP specified amounts.
Class I · High risk
Sucralfate Oral Suspension
Microbial Contamination of Non-Sterile Products: identified as Bacillus cereus.
Class III · Low risk
Aminocaproic Acid Oral Solution
Failed Excipient Specifications: high content of ethylene glycol (EG)
Class III · Low risk
Synthroid
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
The Rock
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
Montelukast Sodium Tablets
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
Certain Over-The-Counter
CGMP Deviations: OTC products were stored outside of labeled temperature requirements.
Class II · Moderate risk
Clinical TREAT Antifungal Powder
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
VANCOmycin HCI PF
Labeling: Not Elsewhere Classified
Class III · Low risk
VANCOmycin HCI PF
Labeling: Not Elsewhere Classified
Class III · Low risk
Oxytocin synthetic
Labeling: Not Elsewhere Classified
Class III · Low risk
Bupropion Hydrochloride Extended-Release Tablets USP
Failed Dissolution Specifications
Class III · Low risk
Epinephrine-Lidocaine HCl
Subpotent: Failing Test Results for Epinephrine
Class I · High risk
2% Lidocaine HCl Injection
Presence of Particulate Matter: identified as glass.
Class I · High risk
1% Lidocaine HCl Injection
Presence of Particulate Matter: identified as glass.