Class II · Moderate risk
Lipo 8 Injection USP 200 mg/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
FDA drug recalls in 2014
Every FDA drug recall initiated in 2014, newest first, with its risk class, status and the reason the FDA recorded. Use the cause and risk filters to narrow the year down.
1,309 recalls, newest first.
Class II · Moderate risk
Vitamin B12 Hydroxocobalamin 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
B Complex for Injection USP with Methylcobalamin 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 Cyanocobalamin 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
Super MIC B Complex for L-Carnitine for Injection USP with Methylcobalamin 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
MIC 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 5000 Injection USP 5000 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 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
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.