Class II · Moderate risk
Vitamin B6 Pyridoxine HCL for Injection USP
Marketed without an Approved NDA/ANDA; IM and SQ injectable products are being recalled because the manufacturing firm is not registered with the FDA as a drug manufacturer
FDA Drug Recalls
14,806 recalls, newest first
Class II · Moderate risk
Vitamin B12 Cyanocobalamin Injection USP 1000 mcg/ml
Marketed without an Approved NDA/ANDA; IM and SQ injectable products are being recalled because the manufacturing firm is not registered with the FDA as a drug manufacturer
Class II · Moderate risk
BCAA 4% Branched Chain Amino Acid Injection USP
Marketed without an Approved NDA/ANDA; IM and SQ injectable products are being recalled because the manufacturing firm is not registered with the FDA as a drug manufacturer
Class II · Moderate risk
Vitamin B12 Methylcobalamin Injection USP 1000 mcg/ml
Marketed without an Approved NDA/ANDA; IM and SQ injectable products are being recalled because the manufacturing firm is not registered with the FDA as a drug manufacturer
Class II · Moderate risk
Vitamin B12 Methylcobalamin with MIC Injection USP 1000 mcg/ml
Marketed without an Approved NDA/ANDA; IM and SQ injectable products are being recalled because the manufacturing firm is not registered with the FDA as a drug manufacturer
Class II · Moderate risk
Doctor's Best Red Yeast Rice 1200
Marketed Without an Approved NDA/ANDA: FDA analysis discovered undeclared lovastatin, making this an unapproved new drug.
Class III · Low risk
Tolterodine Tartrate Tablets
Failed Impurities/Degradation Specifications; Out of specification for lactol and total impurities.
Class III · Low risk
Famotidine for Oral Suspension
Failed Impurity/Degradation Specification; 12-month stability time point
Class III · Low risk
Diltiazem HCl Extended Release Capsules
Failed Impurities/Degradation Specifications: High out-of-specification results for a related compound obtained during routine stability testing.
Class III · Low risk
Cardura XL
Failed Impurities/Degradation Specifications: Product from this lot may not meet specifications for a product degradant.
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