FDA Drug · 2021
FDA Drug recalls in 2021
RecallRadar indexes 1,016 FDA Drug recall notices published in 2021. By classification: 135 Class I, 779 Class II, 102 Class III.
- Daytrana (methylphenidate transdermal system), Delivers 10 mg over 9 hours (1.1 mg/hr), 30 Patches (NDC 68968-5552-1) per box (NDC 68968-55…
FDA Drug · Class II · 2021-06-02 · Noven Pharmaceuticals - AcetaZOLAMIDE Tablets, USP 125 mg 100 Tablets Rx only NDC 23155-287-01 Manufactured for: Heritage Pharmaceuticals Inc
FDA Drug · Class II · 2021-06-02 · Cardinal Health - Sodium Sulfacetamide 9.8% & Sulfur 4.8% Cleanser (sodium sulfacetamide 9.8% and sulfur 4.8%) Net Wt. 10 oz. (285 g) Rx Only NDC 50096-502-1…
FDA Drug · Class II · 2021-06-02 · Cardinal Health - PENICILLIN V POT for Oral Solution, USP 125mg/5mL 100mL (when mixed) Rx Only, Manufactured for: Teva Pharmaceuticals USA, Inc., North Wales…
FDA Drug · Class II · 2021-06-02 · Cardinal Health - BROMFENAC OPHTHALMIC SOLUTION 0.09% 1.7ML NDC/UPC 62332-508-17
FDA Drug · Class II · 2021-06-02 · Cardinal Health - Intrarosa Prasterone Vaginal Inserts 6.5 mg 28 inserts/applicators Rx Only Manufactured for: Ednoceutics, Inc
FDA Drug · Class II · 2021-06-02 · Cardinal Health - Theophylline (Anhydrous) Extended-Release Tablets 400 mg 100 Tablets Rx Only NDC 68462-380-01 Manufactured by: Glenmark Pharmaceuticals Lim…
FDA Drug · Class II · 2021-06-02 · Cardinal Health - MURO-128 2% 15ML OPTH
FDA Drug · Class II · 2021-06-02 · Cardinal Health - Nadolol Tablets, USP 40 mg 100 Tablets Rx Only NDC 69097-868-07 Manufactured for: Cipla USA Inc. 9100 S. Dadeland Blvd., Suite 1599 Miami,…
FDA Drug · Class II · 2021-06-02 · Cardinal Health - Tuberculin Purified Protein Derivative (Mantous) TUBERSOL, Stabilized Solution 5 US Units, Rx Only Sanofi Pasteur Limited, NDC 49281-752-21
FDA Drug · Class II · 2021-06-02 · Cardinal Health - Trokendi XR (topiramate) extended-release capsules 100 mg 30 Capsules Rx only, Manufactured by: Catalent Pharma Solutions Winchester, KY 40…
FDA Drug · Class II · 2021-06-02 · Cardinal Health - LEUCOVORIN 15MG 24
FDA Drug · Class II · 2021-06-02 · Cardinal Health - ADVAIR HFA 45-21MCG 12GM
FDA Drug · Class II · 2021-06-02 · Cardinal Health - Fexofenadine Hydrochloride Tablets, 180 mg Antihistamine Non-Drowsy 100 Tablets 180 mg Each NDC 45802-571-78 Distributed By Perrigo Allegan…
FDA Drug · Class II · 2021-06-02 · Cardinal Health - TRAVOPROST OPHTHALMIC SOLUTION, USP 0.004% 2.5ML
FDA Drug · Class II · 2021-06-02 · Cardinal Health - Rectiv (nitroglycerin) Ointment 0.4% For Intra-anal Use Only 30 g Rx Only NDC 58914-301-80 Mfd. by: Pharbil Waltrop GmbH, Im Wirrigen 25, 4…
FDA Drug · Class II · 2021-06-02 · Cardinal Health - VITAMIN D3 25MCG 180 TABLETS
FDA Drug · Class II · 2021-06-02 · Cardinal Health - Spiriva HandiHaler (tiotropium bromide inhalation powder) For Oral Inhalation Only 18 mcg (as tiotropium) per capsule Rx only NDC 0597-0075…
FDA Drug · Class II · 2021-06-02 · Cardinal Health - ERYTHROMYCIN TABLETS, USP 250MG 30
FDA Drug · Class II · 2021-06-02 · Cardinal Health - FLOVENT DISKUS 100MCG 60
FDA Drug · Class II · 2021-06-02 · Cardinal Health - Synjardy XR (empagliflozin and metformin) hydrochloride extended-release) Tablets 12.5 mg/1000 mg 60 tablets Rx only NDC 0597-0300-45 Dist.…
FDA Drug · Class II · 2021-06-02 · Cardinal Health - TRELEGY ELLIPTA (FLUTICASONE FUROATE, UMEDIDINIUM AND VILANTEROL INHALATION POWDER) 100-62.5-25MCG 60
FDA Drug · Class II · 2021-06-02 · Cardinal Health - Darifenacin Extended-release Tablets 15 mg 30 Tablets Rx only, Manufactured by: Torrent Pharmaceuticals, LTD Indrad-382 721, India Manufact…
FDA Drug · Class II · 2021-06-02 · Cardinal Health - BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE TABLETS 2.5 mg/6.25 mg, 100-count bottles, Rx Only, Distributed by: Teva Pharmaceuticals USA, I…
FDA Drug · Class II · 2021-06-02 · Cardinal Health - DIBUCAINE TOPICAL ANESTHETIC 1% HEMORRHOIDAL OINTMENT 28GM
FDA Drug · Class II · 2021-06-02 · Cardinal Health - Daytrana (methylphenidate transdermal system), Delivers 15 mg over 9 hours (1.6 mg/hr), 30 Patches (NDC 68968-5553-1) per box (NDC 68968-55…
FDA Drug · Class II · 2021-06-02 · Noven Pharmaceuticals - NP Thyroid 30 Thyroid Tablets, USP 1/2 grain (30 mg), packaged in a) 100-count bottles (NDC 42192-329-01) and b) 7-count bottles (NDC 42192…
FDA Drug · Class I · 2021-06-02 · Acella Pharmaceuticals - CLINDAMYCIN HYDROCHLORIDE CAPSULES, USP,150MG 100-count bottles, Rx Only, Manufactured by: Ohm Laboratories Inc
FDA Drug · Class II · 2021-06-02 · Cardinal Health - Tylenol Acetaminophen Pain Regular Strength Liquid Gels Pain Reliever Fever Reducer 20 Liquid Gels 325 mg each NDC 50580-487-20
FDA Drug · Class II · 2021-06-02 · Cardinal Health - Collagenase Santyl Ointment 250 units/g 30 grams Rx Only Marketed by Smith & Nephew, Inc., Fort Worth, TX 76107, NDC 50484-010-30
FDA Drug · Class II · 2021-06-02 · Cardinal Health - PREGABALIN CAPSULES 300MG 90
FDA Drug · Class II · 2021-06-02 · Cardinal Health - Briviact (brivaracetam) tablets 50 mg, 60-count bottle, Rx only Manufactured for UCB, Inc
FDA Drug · Class II · 2021-06-02 · Cardinal Health - TRAZODONE HYDROCHLORIDE TABLETS, USP 50MG 100 TABLET 10X10UD
FDA Drug · Class II · 2021-06-02 · Cardinal Health - Vitamin D3 Cholecalciferol 50,000 IU Dietary Supplement 12 Capsules NDC 75834-020-12 Marketed by: Nivagen Pharmaceuticals, Inc
FDA Drug · Class II · 2021-06-02 · Cardinal Health - Edarbi (azilsartan medoxomil) tablets 80 mg 30 Tablets Rx Only NDC 60631-080-30 Manufactured for: arbor Pharmaceuticals Atlanta, GA 30328
FDA Drug · Class II · 2021-06-02 · Cardinal Health - PROMETHAZINE PLAIN ORAL SOLUTION 6.25MG/5ML 473ML
FDA Drug · Class II · 2021-06-02 · Cardinal Health - NAT B VIT D3 2000U 100
FDA Drug · Class II · 2021-06-02 · Cardinal Health - Ilevro (nepafenac ophthalmic suspension) 0.3% 3 mL Sterile Rx Only NDC 0065-1750-14 Alcon Laboratories, Inc. 6201 South Freeway Fort Worth,…
FDA Drug · Class II · 2021-06-02 · Cardinal Health - Triumeq (abacavir, dolutegravir, and lamivudine) 600 mg/50 mg/300 mg Tablets 30 Tablets Rx Only NDC 49702-231-13 Manufactured for: Viiv Hea…
FDA Drug · Class II · 2021-06-02 · Cardinal Health - MICONAZOLE 7 2% 45GM APL
FDA Drug · Class II · 2021-06-02 · Cardinal Health - VITAMIN D3 25MCG 90 TABLETS
FDA Drug · Class II · 2021-06-02 · Cardinal Health - Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide Oral Syrup Net: 1 Pint (473 mL) Bulk Container-Not…
FDA Drug · Class II · 2021-06-02 · Cardinal Health - Benzoyl Peroxide 10% Acne Medication Wash Net Wt 5 oz (142 g) Distributed By Perrigo Allegan, MI 49010, NDC 45802-318-01
FDA Drug · Class II · 2021-06-02 · Cardinal Health - METHOCARBAMOL 500MG 500
FDA Drug · Class II · 2021-06-02 · Cardinal Health - Phenobarbital Tablets, USP 32.4 mg 100 tablets Rx only NdC 13517-111-01 Manufactured for: e5 Pharma, LLC., Boca Raton, FL 33432
FDA Drug · Class II · 2021-06-02 · Cardinal Health - Amlodipine and Olmesartan Medoxomil Tablets 10 mg/20 mg 30 Tablets Rx Only NDC 33342-192-07 Manufactured for: Macleods Pharma USA, Inc
FDA Drug · Class II · 2021-06-02 · Cardinal Health - xigduo XR (dapgliflozin/metformin HCl extended-release) tablets 10 mg/1000 mg 30 Tablets Rx only NDC 0310-6280-30 Manufactured for: AstraZe…
FDA Drug · Class II · 2021-06-02 · Cardinal Health - Budesonide and Formoterol Fumarate Dihydrate Inhalation Aerosol 80/4.5 budesonide 80 mcg/formoterol fumarate dihydrate 4.5 mcg Inhalation A…
FDA Drug · Class II · 2021-06-02 · Cardinal Health - Proair HFA (albuterol sulfate) Inhalation Aerosol 90 mcg per actuation With Dose Counter 200 Metered Inhalation 8,5 g Net Contents Rx only…
FDA Drug · Class II · 2021-06-02 · Cardinal Health - Synthroid (levothyroxine sodium tablets, USP) in all pack sizes, styles and concentrations Rx only Abbott Laboratories North Chicago, IL
FDA Drug · Class II · 2021-06-02 · Cardinal Health - VITAMIN D3 50MCG 100 CALC
FDA Drug · Class II · 2021-06-02 · Cardinal Health - Amantadine Hydrochloride Tablets 100 mg 100-count bottle, Rx Only Manufactured by Upsher-Smith Laboratories, Inc
FDA Drug · Class II · 2021-06-02 · Cardinal Health - HySept Solution 0.25% Sodium Hypochlorite Solution 473 mL (16 fl. oz.) NDC 39328-063-25 Manufactured in USA Patrin Pharma, Skokie, IL 60076
FDA Drug · Class II · 2021-06-02 · Cardinal Health - Arnuity Ellipta (fluticasone furoate inhalation powder) 200 mcg 1 Ellipta Inhaler containing 1 Foil Strip of 30 Blisters Rx Only NDC 0173-0…
FDA Drug · Class II · 2021-06-02 · Cardinal Health - Banophen Diphenhydramine HCl 25 mg Antihistamine 100 capsules NDC 0904-5306-60 Distributed by: Major Pharmaceuticals 31778 Enterprise Drive…
FDA Drug · Class II · 2021-06-02 · Cardinal Health - AMOXICILLIN 500MG 100
FDA Drug · Class II · 2021-06-02 · Cardinal Health - OFLOXACIN 0.3% 5ML OPTH
FDA Drug · Class II · 2021-06-02 · Cardinal Health - Infants Aqueous Vitamin D Oral Drops 400 IU/mL 50 mL (1 2/3 fl oz) Manufactrued by: Silarx Pharmaceuticals, Inc. 19 West Street Spring Vall…
FDA Drug · Class II · 2021-06-02 · Cardinal Health - Vitamin D3 Cholecalciferol 50,000 IU Dietary Supplement 100 Capsules NDC 75834-020-01 Marketed by: Nivagen Pharmaceuticals, Inc
FDA Drug · Class II · 2021-06-02 · Cardinal Health - HYDROCORTISONE ACET 30MG 12
FDA Drug · Class II · 2021-06-02 · Cardinal Health - Atorvastatin Calcium Tablets, USP 10 mg*, Rx Only, 500 count bottle, Mfd By: Dr. Reddy's Laboratories Limited, Bachupally 500 090, India, N…
FDA Drug · Class III · 2021-06-02 · Dr Reddy S Laboratories - NEOMYCIN SULF TABLETS, USP, 500mg, 100-count bottle, Rx Only, Distributed by: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC: 0…
FDA Drug · Class II · 2021-06-02 · Cardinal Health - edarbyclor Azilsartan Medoxomil and Chlorthalidone Tablets 40 mg*/25 mg *Each tablet contains: 42.68 mg azilsartan kamedoxomil (equivalent…
FDA Drug · Class II · 2021-06-02 · Cardinal Health - LOTEMAX SM (loteprednol etabonate ophthalmic gel) 0.38% 5GM
FDA Drug · Class II · 2021-06-02 · Cardinal Health - RISPERIDONE 1MG/ML 30ML
FDA Drug · Class II · 2021-06-02 · Cardinal Health - medroxyprogesterone acetate injectable suspension, USP, 150MG/ML 1ML, Rx Only, Distributed by: Greenstone LLC, Peapack, NJ 07977, NDC 59762…
FDA Drug · Class II · 2021-06-02 · Cardinal Health - INTEGRA 325/40/3mg 90-count bottle, NDC: 52747-710-60
FDA Drug · Class II · 2021-06-02 · Cardinal Health - TIROSINT(levothyroxine sodium) capsules 175MCG 3 blisters X10 capsules
FDA Drug · Class II · 2021-06-02 · Cardinal Health - INVEGA SUSTENNA 156MG/1ML
FDA Drug · Class II · 2021-06-02 · Cardinal Health - Levofloxacin Injection in 5% Dextrose 500 mg in 100 mL 5% Dextrose (5 mg/mL) 24x100 mL Single Dose Flexible Containers NDC 0143-9721-24 Wes…
FDA Drug · Class II · 2021-06-02 · Cardinal Health - Ferrous Sulfate 75 mg (equivalent to 15 mg Iron) Per 1.0 mL Alcohol 0.2% v/v Drops Iron Supplement Drops For Infants and Toddlers 50 mL (1…
FDA Drug · Class II · 2021-06-02 · Cardinal Health - NP Thyroid 120 Thyroid Tablets, USP 2 grain (120 mg), packaged in a) 100-count bottles (NDC 42192-328-01) and b) 7-count bottles (NDC 42192…
FDA Drug · Class I · 2021-06-02 · Acella Pharmaceuticals - BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMIDE SYRUP 10-30-2MG/5ML 473ML
FDA Drug · Class II · 2021-06-02 · Cardinal Health - Desvenlafaxine Extended-Release Tablets 25 mg 30 Tablets Rx Only NDC 0591-4060-30 Manufactured by: Actavis Laboratories FL, Inc
FDA Drug · Class II · 2021-06-02 · Cardinal Health - Benztropine Mesylate Tablets, USP in all pack sizes, styles and strengths Manufactured for: Qualitest Pharmaceuticals Huntsville, AL 35811
FDA Drug · Class II · 2021-06-02 · Cardinal Health - FENOFIBRATE CAPSULES, UPS 67MG 100 CAPSULES NDC/UPC 27241-118-04
FDA Drug · Class II · 2021-06-02 · Cardinal Health - COSOPT (Dorzolamide Hydrochloride-Timolol Maleate Ophthalmic Solution) (Dorzolamide Hydrochloride 22.3 mg/mL Timolol Maleate 6.8 mg/mL) 10M…
FDA Drug · Class II · 2021-06-02 · Cardinal Health - Belsomra (suvorexant) tablets 10 mg Each tablet contains 10 mg suvorexant
FDA Drug · Class II · 2021-06-02 · Cardinal Health - ONDANSETRON HCL 4MG 30
FDA Drug · Class II · 2021-06-02 · Cardinal Health - Bevespi Aerosphere (glycopyrrolate and formoterol fumarate) Inhalation Aerosol 9 mcg/4.8 mcg per inhalation For Oral Inhalation only 120 in…
FDA Drug · Class II · 2021-06-02 · Cardinal Health - Timolol Maleate Ophthalmic Solution, USP 0.5% 2.5 mL Sterile For Topical Application In The Eye Rx Only NDC 60505-1005-4 Manufactured by: A…
FDA Drug · Class II · 2021-06-02 · Cardinal Health - CYANOCOBAL Injection 1000MCG/ML 25X1ML
FDA Drug · Class II · 2021-06-02 · Cardinal Health - Belbuca (buprenorphine hydrochloride) buccal film 600 mcg 60 pouches containing 1 buccal film each Rx only NDC 59385-025-60 Manufactured fo…
FDA Drug · Class II · 2021-06-02 · Cardinal Health - TRAMADOL HYDROCHLORIDE TABLETS USP 100MG, 100-count bottle, Rx Only, Manufactured by: Rubicon Research :Private Limited, Ambernath, Dist
FDA Drug · Class II · 2021-06-02 · Cardinal Health - Brilinta ticagrelar tablets 60 mg 60 tablets Rx only NDC 0186-0776-60 Mfd. for: AstraZeneca LP, Wilmington, DE 19850
FDA Drug · Class II · 2021-06-02 · Cardinal Health - Narcan (naloxone HCl) Nasal Spray 4 mg Two Pack This box contains two (2) 4-mg doses of naloxone HCl in 0.1 mL of nasal spray. 0.1 mL intra…
FDA Drug · Class II · 2021-06-02 · Cardinal Health - Valsartan Tablets USP 40 mg 30 Scored Tablets Rx Only NDC 59746-360-30 Manufactured by: Jubilant Generics Ltd
FDA Drug · Class II · 2021-06-02 · Cardinal Health - Polyethylene Glycol 3350 Powder for Solution, Laxative Net Wt 4.1 oz (119 g) 7 Once-Daily Doses NDC 45802-868-01 Distributed by Perrigo All…
FDA Drug · Class II · 2021-06-02 · Cardinal Health - PremierZen Extreme 3000, packaged in cardboard blisters containing one capsule per card, Distributed by Yolo Studio, Cliffside Park, NJ
FDA Drug · Class II · 2021-05-26 · Hyobin - Cequa (cyclosporine ophthalmic solution) 0.09%, 60 Single-Use Vials (6 pouches x 10 single-use vials (0.25 mL each)), Rx only, Manufactured…
FDA Drug · Class III · 2021-05-26 · Sun Pharmaceutical Industries - Delflex Peritoneal Dialysis Solution with 1.5% Dextrose, LM/LC, packaged in a case containing 2 x 6 Liter bags, Rx only, NDC 49230-206-60,…
FDA Drug · Class II · 2021-05-26 · Fresenius Medical Care North America - Preferred Pharmaceuticals Inc., Metformin HCl, Extended Release Tab
FDA Drug · Class II · 2021-05-26 · Preferred Pharmaceuticals - Asenapine Sublingual Tablets, 10 mg, Rx only, 60 Tablets, Sigmapharm Laboratories, LLC, Bensalem, PA, 19020, NDC 42794-017-10
FDA Drug · Class III · 2021-05-26 · Sigmapharm Laboratories - Metoclopramide Injection USP, 10 mg/2 mL (5 mg/mL), 2 mL Single-Use Vial, Rx Only, TEVA Parenteral Medicines, Inc
FDA Drug · Class II · 2021-05-26 · Teva Pharmaceuticals Usa - Haloperidol Decanoate Injection, USP 50 mg/mL, 1 mL Single Dose Vials, Rx Only, Sterile, 10 Vials, Teva Pharmaceuticals, USA, Inc., North W…
FDA Drug · Class II · 2021-05-26 · Teva Pharmaceuticals Usa - Methylprednisolone Acetate Injectable Suspension USP, 40 mg/mL, 10 mL Multiple Dose Vial, Rx Only, Teva Pharmaceuticals USA, Inc., North Wa…
FDA Drug · Class II · 2021-05-26 · Teva Pharmaceuticals Usa - Triple SupremeZen Plus 3500, packaged in cardboard blisters containing one capsule per card, Distributed by Yolo Studio, Cliffside Park, NJ
FDA Drug · Class II · 2021-05-26 · Hyobin - Haloperidol Decanoate Injection, USP 100 mg/mL, 1 mL Single Dose Vials, Rx Only, Sterile, 10 Vials, Teva Pharmaceuticals, USA, Inc., North…
FDA Drug · Class II · 2021-05-26 · Teva Pharmaceuticals Usa - Sterile Water for Inj., USP, 25 x 100 mL Single Dose Vials per carton, Rx only, For Drug Diluent Use Only, Distributed by Hospira, Inc., La…
FDA Drug · Class II · 2021-05-26 · Pfizer - Leucovorin Calcium for Injection, equivalent to leucovorin 350 mg/vial (20 mg/mL), Rx Only, FOR IM or IV Use, Sterile, Teva Parenteral Medi…
FDA Drug · Class II · 2021-05-26 · Teva Pharmaceuticals Usa
Other years
2026 (565) · 2025 (765) · 2024 (657) · 2023 (1,252) · 2022 (1,349) · 2021 (1,016) · 2020 (1,035) · 2019 (2,152) · 2018 (1,426) · 2017 (1,073) · 2016 (1,254) · 2015 (2,020) · 2014 (1,562) · 2013 (1,377) · 2012 (434)