DrugMar 8, 2023
Nephron Sterile Compounding Center Phenylephrine HCl Injection, USP, 1 mg/10 mL recall — FDA D-0359-2023
Lack of Assurance of Sterility
Class IIFDA: TerminatedNephron Sterile Compounding Center LLC
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 148
Records are ordered by the best available source date.
DrugMar 8, 2023
Glimepiride Tablets USP, 1 mg recall — FDA D-0393-2023
CGMP Deviations: recalling drug products following an FDA inspection.
Class IIFDA: TerminatedAccord Healthcare, Inc.
DrugMar 8, 2023
Aripiprazole Tablets, USP 10 mg recall — FDA D-0367-2023
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-0358-2023
Lack of Assurance of Sterility
Class IIFDA: TerminatedNephron Sterile Compounding Center LLC
DrugMar 8, 2023
Tadalafil Tablets, USP 10 mg recall — FDA D-0416-2023
CGMP Deviations: recalling drug products following an FDA inspection.
Class IIFDA: TerminatedAccord Healthcare, Inc.
DrugMar 8, 2023
Glycopyrrolate Injection, USP 1 mg/5 mL (0.2 mg/mL) 5 mL Multiple Dose Vial, x 10 vials recall — FDA D-0398-2023
CGMP Deviations: recalling drug products following an FDA inspection.
Class IIFDA: TerminatedAccord Healthcare, Inc.
DrugMar 8, 2023
Pravastatin Sodium Tablets USP, 80 mg recall — FDA D-0424-2023
CGMP Deviations: recalling drug products following an FDA inspection.
Class IIFDA: TerminatedAccord Healthcare, Inc.
DrugMar 8, 2023
Atorvastatin Calcium Tablets USP, 10 mg* recall — FDA D-0371-2023
CGMP Deviations: recalling drug products following an FDA inspection.
Class IIFDA: TerminatedAccord Healthcare, Inc.
DrugMar 8, 2023
BusPIRone Hydrochloride Tablets USP, 5 mg recall — FDA D-0376-2023
CGMP Deviations: recalling drug products following an FDA inspection.
Class IIFDA: TerminatedAccord Healthcare, Inc.
DrugMar 8, 2023
rOPINIRole Tablets USP 0.25 mg*, 100-count bottle recall — FDA D-0425-2023
CGMP Deviations: recalling drug products following an FDA inspection.
Class IIFDA: TerminatedAccord Healthcare, Inc.
DrugMar 8, 2023
Pirfenidone Tablets 267 mg 90-count bottle x3/Carton recall — FDA D-0419-2023
CGMP Deviations: recalling drug products following an FDA inspection.
Class IIFDA: TerminatedAccord Healthcare, Inc.
DrugMar 8, 2023
Atorvastatin Calcium Tablets USP 40 mg* recall — FDA D-0373-2023
CGMP Deviations: recalling drug products following an FDA inspection.
Class IIFDA: TerminatedAccord Healthcare, Inc.
DrugMar 8, 2023
Volt Candy Wholesale Club PrimeZEN Black 6000 capsule, 2000mg, Male Sexual Performance recall — FDA D-0453-2023
Marketed Without An Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclared sildenafil and tadalafil, ingredients found in FDA approved products for the treatment of…
Class IFDA: TerminatedVolt Candy Wholesale Club
DrugMar 8, 2023
DuPont Nutrition USA BD-102 NF, Microcrystalline Cellulose, NF, Ph recall — FDA D-0352-2023
Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
Class IIIFDA: TerminatedDuPont Nutrition USA, Inc.
DrugMar 8, 2023
Montelukast Sodium Tablets, USP, 10 mg* recall — FDA D-0400-2023
CGMP Deviations: recalling drug products following an FDA inspection.
Class IIFDA: TerminatedAccord Healthcare, Inc.
DrugMar 8, 2023
BusPIRone Hydrochloride Tablets USP 30 mg, 60-count bottle recall — FDA D-0379-2023
CGMP Deviations: recalling drug products following an FDA inspection.
Class IIFDA: TerminatedAccord Healthcare, Inc.
DrugMar 8, 2023
Atorvastatin Calcium Tablets USP 80 mg* recall — FDA D-0374-2023
CGMP Deviations: recalling drug products following an FDA inspection.
Class IIFDA: TerminatedAccord Healthcare, Inc.
DrugMar 8, 2023
Levothyroxine Sodium Tablets, USP 112 mcg, 90 tablets per bottle recall — FDA D-0353-2023
Sub-Potent Drug: Out of specification for assay at the 24 month interval.
Class IIFDA: TerminatedAlvogen, Inc.
DrugMar 8, 2023
Dofetilide Capsules 250 mcg (0.25 mg) 60-count bottle recall — FDA D-0384-2023
CGMP Deviations: recalling drug products following an FDA inspection.
Class IIFDA: TerminatedAccord Healthcare, Inc.
DrugMar 8, 2023
Gabapentin Tablets, USP 600 mg, 500 tablets per bottle recall — FDA D-0354-2023
Presence of Foreign Tablets/Capsules: Pharmacist reported presence of some Gabapentin tablets 800 mg comingled in Gabapentin 600 mg 500 count bottles.
Class IIIFDA: TerminatedSciegen Pharmaceuticals Inc.
Medical DeviceMar 1, 2023
Siemens Healthcare Diagnostics ADVIA Centaur Folate 500 test kit- For in vitro diagnostic recall — FDA Z-1153-2023
Negative bias occurred when whole blood calibration (Atellica IM Fol or ADVIA Centaur FolateBA/FolBA) used to test serum samples.
Class IIFDA: OngoingSiemens Healthcare Diagnostics, Inc.
Medical DeviceMar 1, 2023
Siemens Healthcare Diagnostics ADVIA Centaur Folate 500 test kit (REF)-For in vitro recall — FDA Z-1154-2023
Negative bias occurred when whole blood calibration (Atellica IM Fol or ADVIA Centaur FolateBA/FolBA) used to test serum samples.
Class IIFDA: OngoingSiemens Healthcare Diagnostics, Inc.
Medical DeviceMar 1, 2023
Siemens Healthcare Diagnostics Atellica IM Folate 700 test kit- For in vitro diagnostic use recall — FDA Z-1150-2023
Negative bias occurred when whole blood calibration (Atellica IM Fol or ADVIA Centaur FolateBA/FolBA) used to test serum samples.
Class IIFDA: OngoingSiemens Healthcare Diagnostics, Inc.
Medical DeviceMar 1, 2023
S & MOHR AMERICA, S.A. DE C.V abm Respiratory Care Standart Breating Circuit with Face Mask recall — FDA Z-1160-2023
Incorrect expiration date on product label. The manufacturing date was listed as the expiration date. Correct expiration date is "22.07.2027"
Class IIIFDA: OngoingS & MOHR AMERICA, S.A. DE C.V.
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.