DrugJun 2, 2021
Namzaric recall — FDA D-0418-2021
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class IIFDA: TerminatedCardinal Health Inc.
Monthly breakdown
2021 recalls by month
Select a month to review the recall records reported during that period.
December 2021194 records · 4 categoriesNovember 2021210 records · 4 categoriesOctober 2021342 records · 4 categoriesSeptember 2021300 records · 4 categoriesAugust 2021279 records · 4 categoriesJuly 2021251 records · 4 categoriesJune 2021361 records · 4 categoriesMay 2021226 records · 4 categoriesApril 2021279 records · 4 categoriesMarch 2021241 records · 4 categoriesFebruary 2021320 records · 4 categoriesJanuary 2021226 records · 4 categories
2021 recalls — page 80
Records are ordered by the best available source date.
DrugJun 2, 2021
Cardinal Health Proair HFA (albuterol sulfate) Inhalation Aerosol 90 mcg per actuation With recall — FDA D-0573-2021
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class IIFDA: TerminatedCardinal Health Inc.
DrugJun 2, 2021
NP Thyroid 15 Thyroid Tablets, USP 1/4 grain (15 mg) recall — FDA D-0395-2021
Subpotent Drug
Class IFDA: TerminatedAcella Pharmaceuticals, LLC
DrugJun 2, 2021
Livalo (pitavastatin) tablets 2 mg* recall — FDA D-0500-2021
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class IIFDA: TerminatedCardinal Health Inc.
DrugJun 2, 2021
Belsomra (suvorexant) tablets 20 mg Each tablet contains 20 mg suvorexant recall — FDA D-0523-2021
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class IIFDA: TerminatedCardinal Health Inc.
DrugJun 2, 2021
Cardinal Health Chantix (varenicline) Tablets Continuing Month Box Contains: 4 Continuing recall — FDA D-0554-2021
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class IIFDA: TerminatedCardinal Health Inc.
DrugJun 2, 2021
Cardinal Health Rybelsus (semaglutide) Tablets 7 mg Once daily Each tablet contains 7 mg recall — FDA D-0536-2021
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class IIFDA: TerminatedCardinal Health Inc.
DrugJun 2, 2021
Budesonide and Formoterol Fumarate Dihydrate Inhalation Aerosol 80/4.5 budesonide 80 recall — FDA D-0561-2021
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class IIFDA: TerminatedCardinal Health Inc.
DrugJun 2, 2021
Bevespi Aerosphere recall — FDA D-0434-2021
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class IIFDA: TerminatedCardinal Health Inc.
DrugJun 2, 2021
Cardinal Health COSOPT recall — FDA D-0411-2021
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class IIFDA: TerminatedCardinal Health Inc.
DrugJun 2, 2021
Trokendi XR (topiramate) extended-release capsules 100 mg 30 Capsules recall — FDA D-0570-2021
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class IIFDA: TerminatedCardinal Health Inc.
DrugJun 2, 2021
Balziva 28 Day recall — FDA D-0579-2021
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class IIFDA: TerminatedCardinal Health Inc.
DrugJun 2, 2021
Theophylline (Anhydrous) Extended-Release Tablets 400 mg 100 Tablets recall — FDA D-0485-2021
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class IIFDA: TerminatedCardinal Health Inc.
DrugJun 2, 2021
Daytrana recall — FDA D-0394-2021
Defective Delivery System: The number of customer complaints for ripping patches and tight release/adhesive transfer have exceeded the action limits.
Class IIFDA: OngoingNoven Pharmaceuticals Inc.
DrugJun 2, 2021
Accupac Native Fluoride Toothpaste for Sensitive Teeth, with Fluoride, 5% potassium nitrate recall — FDA D-0598-2021
Labeling: Not Elsewhere Classified; the primary label (tube) may be incorrectly labeled as Fluoride-Free instead of With Fluoride
Class IIFDA: TerminatedAccupac, Inc.
DrugJun 2, 2021
Daytrana recall — FDA D-0393-2021
Defective Delivery System: The number of customer complaints for ripping patches and tight release/adhesive transfer have exceeded the action limits.
Class IIFDA: OngoingNoven Pharmaceuticals Inc.
DrugJun 2, 2021
Cardinal Health Timolol Maleate Ophthalmic Solution, USP 0.5% 2.5 mL Sterile For Topical recall — FDA D-0428-2021
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class IIFDA: TerminatedCardinal Health Inc.
DrugJun 2, 2021
edarbyclor Azilsartan Medoxomil and Chlorthalidone Tablets 40 mg*/25 mg *Each tablet recall — FDA D-0431-2021
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class IIFDA: TerminatedCardinal Health Inc.
DrugJun 2, 2021
Amlodipine and Olmesartan Medoxomil Tablets 10 mg/20 mg 30 Tablets recall — FDA D-0509-2021
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class IIFDA: TerminatedCardinal Health Inc.
DrugJun 2, 2021
Oseltamivir Phosphate for Oral Suspension 6 mg/mL* *Each mL contains 6 mg oseltamivir base recall — FDA D-0423-2021
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class IIFDA: TerminatedCardinal Health Inc.
DrugJun 2, 2021
Cardinal Health Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan recall — FDA D-0596-2021
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class IIFDA: TerminatedCardinal Health Inc.
DrugJun 2, 2021
Cardinal Health FaBB Vitamin B6 recall — FDA D-0488-2021
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class IIFDA: TerminatedCardinal Health Inc.
DrugJun 2, 2021
Cardinal Health Sodium Sulfacetamide 9.8% & Sulfur 4.8% Cleanser recall — FDA D-0462-2021
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class IIFDA: TerminatedCardinal Health Inc.
DrugJun 2, 2021
Chantix (varenicline) Tablets Continuing Month Box Contains: 4 Continuing Weeks recall — FDA D-0555-2021
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class IIFDA: TerminatedCardinal Health Inc.
About the 2021 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.