Class I · High risk
Pink Bikini capsules
Marketed without an approved NDA/ANDA: Product contains undeclared Sibutramine, Phenolphthalein and/or Diclofenac.
FDA Drug Recalls
14,806 recalls, newest first
Class III · Low risk
Lumizyme (alglucosidase alpha)
Labeling: Incorrect or Missing Lot and/or Exp Date
Class III · Low risk
Quinapril Tablets USP 5 mg
Failed Impurities/Degradation Specifications; Impurity A
Class I · High risk
LIPO ESCULTURA capsules
Marketed Without An Approved NDA/ANDA: Tainted product marketed as a dietary supplement. Product found to be tainted with sibutramine, an appetite suppressant that was withdrawn from the U.S. market in October 2010 for safety reasons, and diclofenac, a prescription non-steroidal anti-inflammatory drug, making this an unapproved drug.
Class II · Moderate risk
Ventolin HFA
Defective Delivery System: Some canisters may not contain sufficient propellant to deliver the labeled claim of 200 actuations through the end of shelf life.
Class III · Low risk
Norpace CR
Failed Dissolution Specification
Class II · Moderate risk
Oxygen
cGMP Deviations; trailer may not have met GMP requirements prior to filling
Class III · Low risk
Meclizine Hydrochloride Tablets
Failed Impurities/Degradation Specifications: Out of specification for impurities.
Class III · Low risk
Meclizine Hydrochloride Tablets
Failed Impurities/Degradation Specifications: Out of specification for impurities.
Class I · High risk
SUPER HERBS 350 mg
Marketed without an approved NDA/ANDA - presence of undeclared sibutramine, desmethylsibutramine (an active metabolite of sibutramine) and/or phenolphthalein.
Class III · Low risk
NABUMETONE Tablets USP
Labeling: Not Elsewhere Classified: Lack of leaflets and approved labels on bottles.
Class II · Moderate risk
Dextroamphetamine Saccharate
Failed Impurities/Degradation Specifications: High out of specification test result for impurities during stability testing.
Class II · Moderate risk
tubby todd Bath Co
Microbial Contamination of Non-Sterile Products: Consumer complaint and subsequent testing found lot to be out of specification for mold.
Class II · Moderate risk
SyrSpend SF
Microbial Contamination of Non-Sterile Products: Syrspend SF and Syrspend SF Grape Flavor are being recalled due to the presence of yeast.
Class II · Moderate risk
SyrSpend SF
Microbial Contamination of Non-Sterile Products: Syrspend SF and Syrspend SF Grape Flavor are being recalled due to the presence of yeast.
Class II · Moderate risk
SyrSpend SF
Microbial Contamination of Non-Sterile Products: Syrspend SF and Syrspend SF Grape Flavor are being recalled due to the presence of yeast.
Class II · Moderate risk
Rocuronium Bromide 50 MG/5ML INJ.
Labeling: Incorrect Instructions; RemedyRepack, Inc. a relabeler, is recalling these products due to incorrect storage instructions.
Class II · Moderate risk
Novolin 70/30
Labeling: Incorrect Instructions; RemedyRepack, Inc. a relabeler, is recalling these products due to incorrect storage instructions.
Class II · Moderate risk
Lorazepam 2 mg/mL Inj.
Labeling: Incorrect Instructions; RemedyRepack, Inc. a relabeler, is recalling these products due to incorrect storage instructions.
Class II · Moderate risk
Ascorbic Acid 500 MG/ML Inj.
Labeling: Incorrect Instructions; RemedyRepack, Inc. a relabeler, is recalling these products due to incorrect storage instructions.
Class II · Moderate risk
Vitamin B-Complex 100
Labeling: Incorrect Instructions; RemedyRepack, Inc. a relabeler, is recalling these products due to incorrect storage instructions.
Class II · Moderate risk
Bicillin L-A 600000 Units/mL Inj.
Labeling: Incorrect Instructions; RemedyRepack, Inc. a relabeler, is recalling these products due to incorrect storage instructions.
Class II · Moderate risk
Humulin 70/30
Labeling: Incorrect Instructions; RemedyRepack, Inc. a relabeler, is recalling these products due to incorrect storage instructions.
Class II · Moderate risk
3-in-1 TPN formula daily+overfill Bag
Lack of Assurance of Sterility
Class II · Moderate risk
0.9% Sodium Chloride/MVI injection 2000 mL Bag
Lack of Assurance of Sterility