Class III · Low risk Terminated
Glycopyrrolate Injection
Reason Failed Impurities/Degradation Specifications: elevated levels of Benzaldehyde impurity was found in investigative samples (retain samples).
FDA Drug Recalls
14,801 recalls, newest first
Class II · Moderate risk Terminated
Amoxicillin and Clavulanate Potassium Tablets
Reason Presence of Foreign Substance: Customer complaint of a foreign substance identified as nylon cable tie
Class II · Moderate risk Terminated
Desmopressin Acetate Tablets
Reason GMP Deviations: Product bottle may be absent of desiccant.
Class II · Moderate risk Terminated
Desmopressin Acetate Tablets
Reason GMP Deviations: Product bottle may be absent of desiccant.
Class II · Moderate risk Terminated
Caduet
Reason Defective Container: products potentially could have been packaged in defective bottles, with a notched rim, that could cause inadequate foil sealing resulting in lack of moisture protection.
Class II · Moderate risk Terminated
Caduet
Reason Defective Container: products potentially could have been packaged in defective bottles, with a notched rim, that could cause inadequate foil sealing resulting in lack of moisture protection.
Class II · Moderate risk Terminated
Major Extra Strength Acetaminophen Tablets
Reason Presence of Foreign Tablets/Capsules: Complaint involving one Women's Prenatal dietary supplement tablet commingled in a bottle of Extra Strength Acetaminophen 500 mg contents 1000 count bottle.
Class II · Moderate risk Terminated
Leader Extra Strength Acetaminophen Tablets
Reason Presence of Foreign Tablets/Capsules: Complaint involving one Women's Prenatal dietary supplement tablet commingled in a bottle of Extra Strength Acetaminophen 500 mg contents 1000 count bottle.
Class II · Moderate risk Terminated
Fentanyl Citrate Inj.
Reason Defective Container: confirmed customer reports for vials with loose metal overseal crimp defects, which may result in lack of assurance of sterility.
Class II · Moderate risk Terminated
New! Rompe Pecho MAX Multi Symptoms
Reason Microbial Contamination of Non-Sterile Products
Class II · Moderate risk Terminated
Rompe Pecho EX Expectorant
Reason Microbial Contamination of Non-Sterile Products
Class II · Moderate risk Terminated
Rompe Pecho CF Cold & Flu with Honey
Reason Microbial Contamination of Non-Sterile Products
Class II · Moderate risk Terminated
Ethacrynate Sodium for Injection
Reason cGMP Deviations
Class III · Low risk Terminated
Clonidine Hydrochloride Tablets
Reason Failed Impurities/Degredation Specifications: This recall is initiated as a precautionary measure due to potential migration of Benzophenone at very low level into product from container label.
Class III · Low risk Terminated
Tramadol Hydrochloride Tablets USP CIV
Reason Labeling: Incorrect package insert - Patient leaflets for the specified lots of unscored tablets contain language relative to a 25 mg dosing titration that necessitates the use of a scored 50 mg tablet.
Class II · Moderate risk Terminated
Glycopyrrolate Tabs
Reason Failed Impurities/Degradation Specification: High Out of Specification Results for Individual Unknown Impurity.
Class II · Moderate risk Terminated
Kushim Tablets
Reason Marketed Without an Approved NDA/ANDA. FDA analysis found product to contain cinobufagin, bufalin, and bufotenine
Class II · Moderate risk Terminated
Atorvastatin Calcium Tablets
Reason Presence of Foreign Tablets/Capsules: Customer complaint that one 20 mg Atorvastatin Calcium Tablet was present in a bottle labeled as and containing eight-nine Atorvastatin Calcium Tablets, USP 10 mg.
Class II · Moderate risk Terminated
Methylphenidate hydrochloride Extended-Release ablets USP
Reason CGMP deviations: Product bottle may be absent of desiccant.
Class II · Moderate risk Terminated
Methylphenidate hydrochloride Extended-Release ablets USP
Reason CGMP deviations: Product bottle may be absent of desiccant.
Class II · Moderate risk Terminated
Desmopressin Acetate Tablets
Reason GMP Deviations: Product bottle may be absent of desiccant.
Class II · Moderate risk Terminated
Desmopressin Acetate Tablets
Reason GMP Deviations: Product bottle may be absent of desiccant.
Class II · Moderate risk Terminated
Solifenacin Succinate Tablets
Reason CGMP Deviations: During manufacturing Solifenacin Succinate Tablets might convert to Solifenacin Tartrate Tablets.
Class II · Moderate risk Terminated
Solifenacin Succinate Tablets
Reason CGMP Deviations: During manufacturing Solifenacin Succinate Tablets might convert to Solifenacin Tartrate Tablets.
Class III · Low risk Terminated
Pioglitazone and Metformin Hydrochloride Tablets
Reason Subpotent Drug: Out of specification assay result, below specification, for two lots of Pioglitazone And Metformin Hydrochloride Tablets.