Class III · Low risk
Discount Drug Mart
Labeling: Incorrect or Missing Lot and/or Expiration date.
FDA Drug Recalls
18,003 recalls, newest first
Class III · Low risk
TRAMADOL HYDROCHLORIDE Tablets
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
Memantine Hydrochloride Extended Release Capsules
Failed Dissolution Specifications: Low out of specification results observed in dissolution test at six-month long-term stability study.
Class III · Low risk
Frovatriptan Succinate Tablets
Labeling: Incorrect or Missing Lot and/or Exp Date: Product incorrectly labeled with an expiration date of August 2022 rather than the correct expiration date of April 2022.
Class I · High risk
Phenytoin Oral Suspension USP
Resuspension Problems: Two lots of Phenytoin Oral Suspension USP 125mg/5mL may coagulate and may not resuspend as per the label copy instructions.
Class III · Low risk
Glycopyrrolate Injection
Failed Impurities/Degradation Specifications: elevated levels of Benzaldehyde impurity was found in investigative samples (retain samples).
Class II · Moderate risk
Amoxicillin and Clavulanate Potassium Tablets
Presence of Foreign Substance: Customer complaint of a foreign substance identified as nylon cable tie
Class II · Moderate risk
Desmopressin Acetate Tablets
GMP Deviations: Product bottle may be absent of desiccant.
Class II · Moderate risk
Desmopressin Acetate Tablets
GMP Deviations: Product bottle may be absent of desiccant.
Class II · Moderate risk
Caduet (amlodipine besylate/atorvastatin calcium)
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
Caduet (amlodipine besylate/atorvastatin calcium)
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
Major Extra Strength Acetaminophen Tablets
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
Leader Extra Strength Acetaminophen Tablets
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
Fentanyl Citrate Inj.
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
New! Rompe Pecho MAX Multi Symptoms
Microbial Contamination of Non-Sterile Products
Class II · Moderate risk
Rompe Pecho EX Expectorant
Microbial Contamination of Non-Sterile Products
Class II · Moderate risk
Rompe Pecho CF Cold & Flu with Honey
Microbial Contamination of Non-Sterile Products
Class II · Moderate risk
Ethacrynate Sodium for Injection
cGMP Deviations
Class III · Low risk
Clonidine Hydrochloride Tablets
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
Tramadol Hydrochloride Tablets USP CIV
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
Glycopyrrolate Tabs
Failed Impurities/Degradation Specification: High Out of Specification Results for Individual Unknown Impurity.
Class II · Moderate risk
Kushim Tablets
Marketed Without an Approved NDA/ANDA. FDA analysis found product to contain cinobufagin, bufalin, and bufotenine
Class II · Moderate risk
Atorvastatin Calcium Tablets
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
Methylphenidate hydrochloride Extended-Release ablets USP
CGMP deviations: Product bottle may be absent of desiccant.
Class II · Moderate risk
Methylphenidate hydrochloride Extended-Release ablets USP
CGMP deviations: Product bottle may be absent of desiccant.