Class III · Low risk
Amlodipine besylate and Atorvastatin calcium tablets
Subpotent drug
FDA Drug Recalls
14,806 recalls, newest first
Class III · Low risk
Amlodipine besylate and Atorvastatin calcium tablets
Subpotent drug
Class III · Low risk
Amlodipine besylate and Atorvastatin calcium tablets
Subpotent drug
Class III · Low risk
Loratadine Orally Disintegrating Tablets USP
Superpotent Drug: Out Of Specification (OOS) result for Assay.
Class II · Moderate risk
Sodium Sulfacetamide 9% and Sulfur 4.5% Wash Kit with Sunscreen
Microbial Contamination of Non-Sterile Products: Product failed USP Microbial Limits Test.
Class II · Moderate risk
Sodium Sulfacetamide 9% and Sulfur 4.5% Wash Kit
Microbial Contamination of Non-Sterile Products: Product failed USP Microbial Limits Test.
Class II · Moderate risk
Ortho-Cept
Subpotent Drug
Class II · Moderate risk
Azithromycin 500 mg tablets
cGMP Deviations: This recall is a result of the original manufacturer's recall, in which the firm did not adequately investigate customer complaints.
Class II · Moderate risk
Azithromycin Tablets
cGMP Deviations: This recall is a result of the original manufacturer's recall, in which the firm did not adequately investigate customer complaints.
Class II · Moderate risk
PHENYLephrine HCl 50 mg in 0.9% Sodium Chloride 250 mL bag
Labeling: Label Mix-Up: Product is incorrectly labeled as phenylephrine 50 mg in 0.9% sodium chloride rather than phenylephrine 50 mg in 5% dextrose.
Class II · Moderate risk
Kabiven
Labeling: Label Error on Declared Strength: Labeled 3.1% Amino Acids but contains 3.3% Amino Acids
Class I · High risk
Adrucil (fluorouracil injection, USP)
Presence of Particulate Matter: Black particulate matter was identified as aggregate of silicone rubber pieces from a filler diaphragm and fluorouracil crystals.
Class III · Low risk
Levalbuterol Inhalation Solution
Failed Impurities/Degradation Specifications: Product is out of specification for a known degradant.
Class II · Moderate risk
Alinia (nitazoxanide)
Failed Stability Specifications: Product failed to meet 12 months long term stability specification for viscosity
Class II · Moderate risk
Bi-Est (estriol,estradiol)
Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.
Class II · Moderate risk
Bi-Est (estriol,estradiol)
Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.
Class II · Moderate risk
Estradiol cream
Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.
Class II · Moderate risk
Bi-Est (estriol,estradiol)
Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.
Class II · Moderate risk
Estriol
Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.
Class II · Moderate risk
Bi-Est (estriol,estradiol)
Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.
Class II · Moderate risk
Estradiol
Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.
Class II · Moderate risk
Estradiol
Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.
Class II · Moderate risk
Tri-Est 80:10:10 Progesterone
Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.
Class II · Moderate risk
Methyl Folate Lyophilized Powder for Injection
Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.
Class II · Moderate risk
Chorionic Gonadotropin/ Hydroxocobalamin Lyophilized Powder Injectable
Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.