Class II · Moderate risk
Venlafaxine Hydrochloride Extended-Release Tablets
Failed Dissolution Specifications: Stability results found the product did not meet the drug dissolution specifications.
FDA Drug Recalls
1,273 recalls, newest first
Class II · Moderate risk
Captomer-250
Marketed Without An Approved NDA/ANDA: Captomer and Captomer-250 are marketed as dietary supplements and labeled to be sourced from Dimercaptosuccinic Acid (DMSA) which is the active ingredient in an FDA approved drug making these products unapproved new drugs.
Class II · Moderate risk
Captomer
Marketed Without An Approved NDA/ANDA: Captomer and Captomer-250 are marketed as dietary supplements and labeled to be sourced from Dimercaptosuccinic Acid (DMSA) which is the active ingredient in an FDA approved drug making these products unapproved new drugs.
Class III · Low risk
DENBLAN Anticavity Fluoride Toothpaste
Stability Data Does Not Support Expiry
Class II · Moderate risk
Heparin Sodium in 5% Dextrose Injection
Lack of Assurance of Sterility: Confirmed consumer report of fluid leaking from primary container of bag.
Class II · Moderate risk
Carbidopa and Levodopa Tablets USP
Failed Tablet/Capsule Specifications: Teva is recalling one lot of Carbidopa and Levodopa Tablets USP, 25mg/100mg due to the potential for superpotent tablets.
Class III · Low risk
APLENZIN¿ (bupropion hydrobromide)
Labeling: Incorrect or Missing Package Insert
Class III · Low risk
APLENZIN¿ (bupropion hydrobromide)
Labeling: Incorrect or Missing Package Insert
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.