Class III · Low risk
APLENZIN¿ (bupropion hydrobromide)
Labeling: Incorrect or Missing Package Insert
FDA Drug Recalls
14,806 recalls, newest first
Class III · Low risk
APLENZIN¿ (bupropion hydrobromide)
Labeling: Incorrect or Missing Package Insert
Class I · High risk
Soliris (eculizumab)
Presence of Particulate Matter: Product failed the appearance for the presence of visible particles under labeled storage condition.
Class II · Moderate risk
Atorvastatin Calcium 40 MG Tablet
Presence of Foreign Tablets/Capsules:179 doses of Valacyclovir HCl 500 mg tablets were repacked in unit dose packslabeled as Atorvastatin Calcium
Class II · Moderate risk
HCG (Human Chorionic Gonadotropin)
Incorrect/Undeclared Excipients: Specific drug products were compounded with an incorrect solvent.
Class II · Moderate risk
HCG (Human Chorionic Gonadotropin)
Incorrect/Undeclared Excipients: Specific drug products were compounded with an incorrect solvent.
Class II · Moderate risk
HCG 125U/Tab Tablet Tritu
Incorrect/Undeclared Excipients: Specific drug products were compounded with an incorrect solvent.
Class II · Moderate risk
HCG (Human Chorionic Gonadotropin)
Incorrect/Undeclared Excipients: Specific drug products were compounded with an incorrect solvent.
Class II · Moderate risk
Diphenhydramine
Incorrect/Undeclared Excipients: Specific drug products were compounded with an incorrect solvent.
Class II · Moderate risk
Mometasone 0.6 mg /60 mL Irrigation solution
Incorrect/Undeclared Excipients: Specific drug products were compounded with an incorrect solvent.
Class II · Moderate risk
Fluvastatin Capsules USP
Failed Tablet/Capsule Specifications: Teva Pharmaceuticals USA, Inc. is voluntarily recalling one lot of Fluvastatin Capsules USP, 20 mg due to a customer complaint trend regarding capsule breakage.
Class I · High risk
LOW Potassium Cardioplegia 792 mL
Non Sterility; microbial contamination identified as Aspergillus species
Class I · High risk
adenosine 90 mg in 0.9% sodium chloride/90 mL
Non Sterility; microbial contamination identified as Aspergillus species
Class I · High risk
del Nido Cardioplegia with Lidocaine 1052.8 ml
Non Sterility; microbial contamination identified as Aspergillus species
Class I · High risk
Pediatric Cardioplegia
Non Sterility; microbial contamination identified as Aspergillus species
Class III · Low risk
Foradil Aerolizer
Failed Stability Specification; out of specification result for particle size distribution during stability testing
Class II · Moderate risk
Dr. Reddy's Metoprolol Succinate Extended Release Tablets
Failed Dissolution Specifications: Failure of dissolution test observed at the 18 month time point.
Class II · Moderate risk
Cefpodoxime Proxetil Tablets
Presence of Foreign Substance: Presence of stainless steel particles.
Class II · Moderate risk
Ciprofloxacin 500 mg tablets
Presence of Foreign Tablets/Capsules: Tramodol 50 mg tablet has been found in a bottle of Ciprofloxacin 500 mg
Class III · Low risk
Vasotec (enalapril maleate)
Labeling: Incorrect or Missing Package Insert: Product is packaged with the incorrect version of the package insert.
Class III · Low risk
Vaseretic (enalapril maleate/hydrochlorothiazide)
Labeling: Incorrect or Missing Package Insert: Product is packaged with the incorrect version of the package outset
Class II · Moderate risk
Isoniazid Tablets
Failed Dissolution Specifications: Stability lots cannot support dissolution past the 36 month time point.
Class II · Moderate risk
Mesalamine
Presence of Particulate Matter: Stainless steel in a chemical reactor dissolved into the API solution and was detected in the finished product.
Class II · Moderate risk
ePHEDrine Sulfate Injection
Labeling: Label Error on Declared Strength; The outer light protective bags, where the ephedrine sulfate injection syringes are stored, were mislabeled with 25 mg/mL in big font and 5 mg/mL in small font, however, the actual syringes were correctly labeled as 25 mg/5 mL.
Class II · Moderate risk
Labetalol Hydrochloride Injection
Presence of Particulate Matter; metal embedded in the glass vial and visible particles floating in the solution