DrugMar 8, 2023
Accord Healthcare Vigabatrin for Oral Solution, USP, 500 mg recall — FDA D-0418-2023
CGMP Deviations: recalling drug products following an FDA inspection.
Class IIFDA: TerminatedAccord Healthcare, Inc.
Monthly breakdown
2023 recalls by month
Select a month to review the recall records reported during that period.
December 2023295 records · 4 categoriesNovember 2023387 records · 4 categoriesOctober 2023214 records · 4 categoriesSeptember 2023253 records · 4 categoriesAugust 2023478 records · 4 categoriesJuly 2023263 records · 4 categoriesJune 2023339 records · 4 categoriesMay 2023410 records · 4 categoriesApril 2023189 records · 4 categoriesMarch 2023788 records · 4 categoriesFebruary 2023253 records · 4 categoriesJanuary 2023205 records · 4 categories
2023 recalls — page 146
Records are ordered by the best available source date.
DrugMar 8, 2023
Dofetilide Capsules, 125 mcg (0.125 mg), 60-count bottle recall — FDA D-0383-2023
CGMP Deviations: recalling drug products following an FDA inspection.
Class IIFDA: TerminatedAccord Healthcare, Inc.
DrugMar 8, 2023
Dofetilide Capsules 500 mcg (0.5 mg), 60-count bottle recall — FDA D-0385-2023
CGMP Deviations: recalling drug products following an FDA inspection.
Class IIFDA: TerminatedAccord Healthcare, Inc.
DrugMar 8, 2023
Aripiprazole Tablets, USP 20 mg recall — FDA D-0369-2023
CGMP Deviations: recalling drug products following an FDA inspection.
Class IIFDA: TerminatedAccord Healthcare, Inc.
DrugMar 8, 2023
BusPIRone Hydrochloride Tablets USP 15 mg recall — FDA D-0377-2023
CGMP Deviations: recalling drug products following an FDA inspection.
Class IIFDA: TerminatedAccord Healthcare, Inc.
DrugMar 8, 2023
Rosuvastatin Tablets, USP, 5 mg* recall — FDA D-0404-2023
CGMP Deviations: recalling drug products following an FDA inspection.
Class IIFDA: TerminatedAccord Healthcare, Inc.
DrugMar 8, 2023
Rosuvastatin Tablets, USP, 10 mg* recall — FDA D-0405-2023
CGMP Deviations: recalling drug products following an FDA inspection.
Class IIFDA: TerminatedAccord Healthcare, Inc.
DrugMar 8, 2023
Glimepiride Tablets USP, 2 mg recall — FDA D-0394-2023
CGMP Deviations: recalling drug products following an FDA inspection.
Class IIFDA: TerminatedAccord Healthcare, Inc.
DrugMar 8, 2023
Glycopyrrolate Injection, USP, 0.4 mg/2 mL (0.2 mg/mL) 2 mL Single Dose Vial X 25 vials recall — FDA D-0397-2023
CGMP Deviations: recalling drug products following an FDA inspection.
Class IIFDA: TerminatedAccord Healthcare, Inc.
DrugMar 8, 2023
DuPont Nutrition USA Avicel PH-200 NF, Microcrystalline Cellulose, NF, Ph recall — FDA D-0351-2023
Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
Class IIIFDA: TerminatedDuPont Nutrition USA, Inc.
DrugMar 8, 2023
Aripiprazole Tablets, USP 2 mg recall — FDA D-0365-2023
CGMP Deviations: recalling drug products following an FDA inspection.
Class IIFDA: TerminatedAccord Healthcare, Inc.
DrugMar 8, 2023
Atorvastatin Calcium Tablets USP 20 mg* recall — FDA D-0372-2023
CGMP Deviations: recalling drug products following an FDA inspection.
Class IIFDA: TerminatedAccord Healthcare, Inc.
DrugMar 8, 2023
Rosuvastatin Tablets, USP 40 mg* recall — FDA D-0407-2023
CGMP Deviations: recalling drug products following an FDA inspection.
Class IIFDA: TerminatedAccord Healthcare, Inc.
DrugMar 8, 2023
Doxazosin Tablets USP, 2 mg recall — FDA D-0387-2023
CGMP Deviations: recalling drug products following an FDA inspection.
Class IIFDA: TerminatedAccord Healthcare, Inc.
DrugMar 8, 2023
Nephron Sterile Compounding Center Norepinephrine Bitartrate in 0.9% Sodium Chloride recall — FDA D-0356-2023
Lack of Assurance of Sterility
Class IIFDA: TerminatedNephron Sterile Compounding Center LLC
DrugMar 8, 2023
Tadalafil Tablets, USP, 20 mg recall — FDA D-0417-2023
CGMP Deviations: recalling drug products following an FDA inspection.
Class IIFDA: TerminatedAccord Healthcare, Inc.
DrugMar 8, 2023
Simvastatin Tablets, USP, 10 mg recall — FDA D-0409-2023
CGMP Deviations: recalling drug products following an FDA inspection.
Class IIFDA: TerminatedAccord Healthcare, Inc.
DrugMar 8, 2023
Simvastatin Tablets USP 80 mg recall — FDA D-0412-2023
CGMP Deviations: recalling drug products following an FDA inspection.
Class IIFDA: TerminatedAccord Healthcare, Inc.
DrugMar 8, 2023
Simvastatin Tablets USP 5 mg recall — FDA D-0408-2023
CGMP Deviations: recalling drug products following an FDA inspection.
Class IIFDA: TerminatedAccord Healthcare, Inc.
DrugMar 8, 2023
Glycopyrrolate Injection, USP 4 mg/20 mL (0.2 mg/mL) 20 mL Multiple Dose Vial, 10vial carton recall — FDA D-0399-2023
CGMP Deviations: recalling drug products following an FDA inspection.
Class IIFDA: TerminatedAccord Healthcare, Inc.
DrugMar 8, 2023
Daptomycin for Injection 350 mg/vial recall — FDA D-0381-2023
CGMP Deviations: recalling drug products following an FDA inspection.
Class IIFDA: TerminatedAccord Healthcare, Inc.
DrugMar 8, 2023
Daptomycin for Injection 500 mg per vial, Single-dose vial recall — FDA D-0382-2023
CGMP Deviations: recalling drug products following an FDA inspection.
Class IIFDA: TerminatedAccord Healthcare, Inc.
DrugMar 8, 2023
Accord Healthcare Phenylephrine Hydrochloride Injection, USP 100 mg/10 mL (10 mg/mL) recall — FDA D-0403-2023
CGMP Deviations: recalling drug products following an FDA inspection.
Class IIFDA: TerminatedAccord Healthcare, Inc.
DrugMar 8, 2023
The Harvard Drug Group Carbidopa and Levodopa Tablets, USP 25 mg/100 mg, 10x10 Unit Dose recall — FDA D-0432-2023
Packaging defect: observed packaging defect, blister packaging inadequately sealed.
Class IIFDA: TerminatedThe Harvard Drug Group
About the 2023 recall archive
This archive groups records by their reported or recall date. It does not imply that every recall was initiated, announced and resolved during the same calendar year. Open the individual record for the exact dates and source details supplied by FDA or NHTSA.