Class II · Moderate risk
Glipizide 2.5 mg Extended-release tablets
Failed Dissolution Specifications: Glipizide 2.5 mg ER Tablets exceeded dissolution specification rates for the 10 hour testing point.
FDA Drug Recalls
1,103 recalls, newest first
Class II · Moderate risk
TAZORAC (tazarotene)
Failed Content Uniformity Specifications
Class II · Moderate risk
TAZORAC (tazarotene)
Failed Content Uniformity Specifications
Class II · Moderate risk
Methylprednisolone Acetate/Lidocaine HCl 40/10 mg/mL Injection
Lack of Processing Controls: Isomeric Pharmacy Solution, LLC announces a voluntary field action for the Methylprednisolone Acetate/Lidocaine HCl 40/10 mg/mL Injection because the sterile injectable products were sterilized too long leading to potential difficulty resuspending particles.
Class II · Moderate risk
TESTOSTERONE CYPIONATE 200mg/ml
Lack of Assurance of Sterility: Aluminum crimps do not fully seal the rubber stopper to the vial on all containers.
Class III · Low risk
5% Lidocaine HCL and 7.5% Dextrose Injection
Failed Stability Specifications: The recalled lots did not meet the specification for color and pH throughout shelf life.
Class III · Low risk
DULOXETINE Delayed-Release Capsules
Labeling; Incorrect or Missing Lot and/or Exp Date; incorrect expiration date on container label is 02/2019, correct expiration date should be 02/2018
Class III · Low risk
Carvediol Tablets
Failed Impurities/Degradation Specifications
Class III · Low risk
Carvediol Tablets
Failed Impurities/Degradation Specifications
Class III · Low risk
Carvediol Tablets
Failed Impurities/Degradation Specifications
Class III · Low risk
Carvediol Tablets
Failed Impurities/Degradation Specifications
Class III · Low risk
buPROPion Hydrochloride Extended Release Tablets USP
Failed Dissolution Specifications
Class II · Moderate risk
Amoxicillin for Oral Suspension USP
Superpotent drug: Out of specification test result for assay during stability testing.
Class II · Moderate risk
Diazepam Injection USP 10mg/2mL
Crystallization: Product contains particulate identified to be crystallized active ingredient.
Class II · Moderate risk
Albuterol Sulfate Syrup
Presence of Foreign Substance; presence of black particles describes generically as cellulose-based bundles of brown fibrous material.
Class II · Moderate risk
Alprazolam Extended-release Tablets
Failed Dissolution Specifications
Class II · Moderate risk
Prostaglandin 200 mcg/ 0.1 mL -- 25 mL GLASS VIAL
Lack of assurance of sterility: This recall includes of all unexpired lots medications containing Calcium Gluconate, Papaverine, Phentolamine, and /or Prostaglandin) due to unsubstantiated validation of beyond use dating.
Class II · Moderate risk
Papaverine 75 mg / Phentolamine 2.5 mg / Prostaglandin 25 mcg -- 4.2 mL GLASS VIAL
Lack of assurance of sterility: This recall includes of all unexpired lots medications containing Calcium Gluconate, Papaverine, Phentolamine, and /or Prostaglandin) due to unsubstantiated validation of beyond use dating.
Class II · Moderate risk
Papaverine 30 mg / Phentolamine 1 mg / mL -- 5 mL GLASS VIAL
Lack of assurance of sterility: This recall includes of all unexpired lots medications containing Calcium Gluconate, Papaverine, Phentolamine, and /or Prostaglandin) due to unsubstantiated validation of beyond use dating.
Class II · Moderate risk
Calcium Gluconate 2.5% -- 20 mL PLASTIC SYRINGE
Lack of assurance of sterility: This recall includes of all unexpired lots medications containing Calcium Gluconate, Papaverine, Phentolamine, and /or Prostaglandin) due to unsubstantiated validation of beyond use dating.
Class II · Moderate risk
Calcium Gluconate 1% -- 1000 mL VIAFLEX IV BAG
Lack of assurance of sterility: This recall includes of all unexpired lots medications containing Calcium Gluconate, Papaverine, Phentolamine, and /or Prostaglandin) due to unsubstantiated validation of beyond use dating.
Class II · Moderate risk
Ondansetron Injection USP 40 mg/20 mL
CGMP Deviations
Class II · Moderate risk
Eptifibatide Injection 75 mg/100 mL
CGMP Deviations
Class II · Moderate risk
Linezolid Injection 600 mg/300 mL Rx Only
CGMP Deviations
Class II · Moderate risk
ARGATROBAN Injection in 0.9% Sodium Chloride 250 mg/250 mL
CGMP Deviations