Class III · Low risk
Cardura XL
Failed Impurities/Degradation Specifications: Product from this lot may not meet specifications for a product degradant.
FDA Drug Recalls
18,003 recalls, newest first
Class III · Low risk
Aspirin DR Enteric Coated Tablets
Failed Dissolution Specification; at the 12 month time interval.
Class II · Moderate risk
Bystolic (nebivolol)
Failed Dissolution Specifications: Drug failed stage III dissolution testing.
Class III · Low risk
Velivet (desogestrel and ethinyl estradiol tablets - triphasic regimen)
Failed Impurities/Degradation Specifications: out of specification impurity test results.
Class III · Low risk
Kariva (desogestrel/ethinyl estradiol and ethinyl estradiol)
Failed Impurities/Degradation Specifications: out of specification impurity test results.
Class III · Low risk
Mircette (desogestrel/ethinyl estradiol and ethinyl estradiol)
Failed Impurities/Degradation Specifications: out of specification impurity test results.
Class III · Low risk
Apri (desogestrel and ethinyl estradiol tablets USP)
Failed Impurities/Degradation Specifications: out of specification impurity test results.
Class I · High risk
Marcaine (bupivacaine HCl)
Presence of Particulate Matter: Confirmed customer complaint of discolored solution with visible metal particles embedded in the glass vial and visible in the solution.
Class II · Moderate risk
Brevibloc Premixed Injection
Presence of Particulate Matter: Complaints received of discolored solution identified as subvisible particles of iron oxide that are agglomerating.
Class II · Moderate risk
Venlafaxine Hydrochloride Extended-Release Tablets
Failed Dissolution Specifications: Stability results found the product did not meet the drug dissolution specifications.
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.