FDA recalls, June 2021: 354 published

82 different companies appear this month.

Risk classification: Class I: 74 · Class II: 266 · Class III: 14

Same month, other agencies:CPSC 14 recallsFSIS 2 recallsNHTSA 97 recalls

Recalls this month

DateProduct
June 2, 2021Spiriva HandiHaler (tiotropium bromide inhalation powder) For Oral Inhalation Only 18 mcg…D-0453-2021Cardinal Health Inc.
June 2, 2021SYMPROIC (NAIDEMEDINE) TABLETS 0.2MG 30 TABLETS; NDC 59385-041-30; RX; TABLETSD-0450-2021Cardinal Health Inc.
June 2, 2021Ivermectin Tablets USP 3 mg 20 Tablets (2 Foil Strips of 10 tablets each) Rx Only NDC 479…D-0471-2021Cardinal Health Inc.
June 2, 2021Fexofenadine Hydrochloride Tablets, 180 mg Antihistamine Non-Drowsy 100 Tablets 180 mg Ea…D-0546-2021Cardinal Health Inc.
June 2, 2021Verapamil Hydrochloride Extended-Release Tablets USP 120 mg Rx Only NDC 68462-292-01 Manu…D-0483-2021Cardinal Health Inc.
June 2, 2021xigduo XR (dapagliflozin/metformin HCl extended-release) tablets 5 mg/1000 mg 60 Tablets …D-0436-2021Cardinal Health Inc.
June 2, 2021BUPRENORPHINE AND NALOXONE SUBLINGUAL FILM 4MG/1MG 30 POUCHES EACH CONTAINING 1 SUBLINGU…D-0422-2021Cardinal Health Inc.
June 2, 2021DIBUCAINE TOPICAL ANESTHETIC 1% HEMORRHOIDAL OINTMENT 28GM ; NDC/UPC 0536-1211-95; OTC; …D-0517-2021Cardinal Health Inc.
June 2, 2021CIPROFLOX/D5W 400/200 24X200ML; NDC/UPC 36000000924; RX; IV SOLUTION (PIGGYBACK)D-0465-2021Cardinal Health Inc.
June 2, 2021Rybelsus (semaglutide) Tablets 7 mg Once daily Each tablet contains 7 mg semaglutide 30 t…D-0536-2021Cardinal Health Inc.
June 2, 2021Vraylar (cariprazine) capsules in all pack sizes, styles and strengths Rx only Distribute…D-0420-2021Cardinal Health Inc.
June 2, 2021Narcan (naloxone HCl) Nasal Spray 4 mg Two Pack This box contains two (2) 4-mg doses of n…D-0473-2021Cardinal Health Inc.
June 2, 2021Darifenacin Extended-release Tablets 7.5 mg 30 Tablets Rx only Manufactured by: Torrent P…D-0583-2021Cardinal Health Inc.
June 2, 2021INTEGRA 325/40/3mg 90-count bottle, NDC: 52747-710-60D-0588-2021Cardinal Health Inc.
June 2, 2021Livalo (pitavastatin) tablets 2 mg* Rx Only NdC 66869-204-90 Manufactured under license f…D-0500-2021Cardinal Health Inc.
June 2, 2021Brilinta ticagrelar tablets 60 mg 60 tablets Rx only NDC 0186-0776-60 Mfd. for: AstraZene…D-0433-2021Cardinal Health Inc.
June 2, 2021Triamcinolone Acetonide Ointment, USP, 0.025% 80g; Rx Only, Distributed by: Perrigo, Alle…D-0551-2021Cardinal Health Inc.
June 2, 2021POLYETHYLENE GLYCOL 3350 Powder for Solution Osmotic Laxative 14 once-daily doses 14 Pack…D-0545-2021Cardinal Health Inc.
June 2, 2021Wild Rice Split Pea Soup, UPC 91675-71000, The Secret Garden, Park Rapids, MN 56470F-0561-2021The Secret Garden of Park Rapids, Inc.
June 2, 2021Budesonide and Formoterol Fumarate Dihydrate Inhalation Aerosol 80/4.5 budesonide 80 mcg/…D-0561-2021Cardinal Health Inc.
June 2, 2021ASMANEX TWST 220MCG 60INH PWD; NDC/UPC 85134102; RX; INHALER MEDICAL INTERNAL - MAY OR MA…D-0525-2021Cardinal Health Inc.
June 2, 2021FLOVENT DISKUS 100MCG 60; NDC/UPC 173060202; RX; INHALER MEDICAL INTERNAL - MAY OR MAY NO…D-0477-2021Cardinal Health Inc.
June 2, 2021Podofilox Topical Solution 0.5% 3.5ML, Rx Only, For Topical Use Only, Manufactured by Per…D-0549-2021Cardinal Health Inc.
June 2, 2021ERYTHROMYCIN TABLETS, USP 250MG 30; NDC/UPC 69238-1484-3; RX; TABLETSD-0424-2021Cardinal Health Inc.
June 2, 2021LOTEMAX SM (loteprednol etabonate ophthalmic gel) 0.38% 5GM; NDC/UPC 24208-0507-07; RX; G…D-0443-2021Cardinal Health Inc.
June 2, 2021Levofloxacin Injection in 5% Dextrose 500 mg in 100 mL 5% Dextrose (5 mg/mL) 24x100 mL S…D-0494-2021Cardinal Health Inc.
June 2, 2021LITHIUM CARB 150MG 100; NDC/UPC 54252625; RX; CAPSULESD-0492-2021Cardinal Health Inc.
June 2, 2021Belsomra (suvorexant) tablets 20 mg Each tablet contains 20 mg suvorexant. This package …D-0523-2021Cardinal Health Inc.
June 2, 2021Nuedexta (dextromethorphan HBr and quinidine sulfate) Capsules 20 mg/10 mg 60 capsules Rx…D-0442-2021Cardinal Health Inc.
June 2, 2021Butorphanol Tartrate Nasal Solution USP 10 mg/mL 2. 5 mL bottles Rx Only NDC 60505-0813-1…D-0427-2021Cardinal Health Inc.
June 2, 2021Tuberculin Purified Protein Derivative (Mantous) TUBERSOL, Stabilized Solution 5 US Units…D-0566-2021Cardinal Health Inc.
June 2, 2021Belbuca (buprenorphine hydrochloride) buccal film 600 mcg 60 pouches containing 1 buccal …D-0449-2021Cardinal Health Inc.
June 2, 2021Cetirizine Hydrochloride Tablets, 10 mg, 300 Count; NDC/UPC 345802919878; OTC; TABLETSD-0548-2021Cardinal Health Inc.
June 2, 2021Ferrous Sulfate 75 mg (equivalent to 15 mg Iron) Per 1.0 mL Alcohol 0.2% v/v Drops Iron S…D-0504-2021Cardinal Health Inc.
June 2, 2021Triumeq (abacavir, dolutegravir, and lamivudine) 600 mg/50 mg/300 mg Tablets 30 Tablets R…D-0486-2021Cardinal Health Inc.
June 2, 20216" Round Croissant Crust 100 Count Bulk, frozen, Net Weight: 6.25 lbs. Croissant Etc. C…F-0629-2021Croissant Etc Corp
June 2, 2021NEOMYCIN SULF TABLETS, USP, 500mg, 100-count bottle, Rx Only, Distributed by: Teva Pharma…D-0574-2021Cardinal Health Inc.
June 2, 2021HYDROCORTISONE 1% 30gm creamD-0565-2021Cardinal Health Inc.
June 2, 2021Methotrexate Injection, USP 50 mg/2mL (25 mg/mL) 5 x 2mL Single-Dose Vials, Sterile, Rx O…D-0553-2021Cardinal Health Inc.
June 2, 2021Synjardy XR (empagliflozin and metformin hydrochloride extended-release) Tablets 25 mg/10…D-0458-2021Cardinal Health Inc.
June 2, 2021ONDANSETRON HCL 4MG 30; NDC/UPC 65862018730; RX; TABLETSD-0440-2021Cardinal Health Inc.
June 2, 2021bupropion Hydrochloride Tablets, USP 75 mg 100 Tablets Rx only NDC 23155-191-01 Manufactu…D-0489-2021Cardinal Health Inc.
June 2, 2021BENZOYL PEROXIDE WASH 5% 148ML; NDC/UPC 0536-1259-63; OTC; LIQUIDD-0518-2021Cardinal Health Inc.
June 2, 2021Nature's Truth Absorbable Calcium 1200 mg plus D3 5000 IU 120 Softgels Dietary Supplement…D-0559-2021Cardinal Health Inc.
June 2, 2021Trokendi XR (topiramate) extended-release capsules 100 mg 30 Capsules Rx only, Manufactur…D-0570-2021Cardinal Health Inc.
June 2, 2021Brew Dr. Uplift Blood Orange Lemon, Yerba Mate *Guayusa * Green Tea, Natural Caffeine Wit…F-0564-2021BREW DR KOMBUCHA LLC
June 2, 2021NP Thyroid 30 Thyroid Tablets, USP 1/2 grain (30 mg), packaged in a) 100-count bottles (N…D-0396-2021Acella Pharmaceuticals, LLC
June 2, 2021Benztropine Mesylate Tablets, USP in all pack sizes, styles and strengths Manufactured fo…D-0537-2021Cardinal Health Inc.
June 2, 2021Synjardy (empagliflozin and metformin hydrochloride) Tablets 12.5 mg/1000 mg 60 tablets R…D-0456-2021Cardinal Health Inc.
June 2, 2021ADVAIR HFA 45-21MCG 12GM; NDC/UPC 173071520; RX; INHALER MEDICAL INTERNAL - MAY OR MAY NO…D-0478-2021Cardinal Health Inc.

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