DL DrugLabelsHubFDA Drug Label Lookup

FDA Drug Recalls

18043 recall notices on file. Class I recalls involve a reasonable probability of serious adverse health consequences or death.

ProductFirmClassificationStatusReport date
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 intranasal spray per unit For use in the nose only Rx only NDC 69547-353-02 Distributed by Adapt Pharma, Inc. Radnor, PA 19087 USA Cardinal Health Inc. Class II Terminated 20210602
Banzel (rufinamide) tablets 200 mg 120 tablets Rx only NDC 62856-582-52 Manufactured by Eisai Co., Ltd. Marketed by Eisai Inc. Woodcliff Lake, NJ 07677 Cardinal Health Inc. Class II Terminated 20210602
Ivermectin Tablets USP 3 mg 20 Tablets (2 Foil Strips of 10 tablets each) Rx Only NDC 4799-806-01 Manufactured for: Edenbridge Pharmaceuticals, LLC Parsippany, NJ 07054 877-381-3336 Cardinal Health Inc. Class II Terminated 20210602
Phenobarbital Tablets, USP 32.4 mg 100 tablets Rx only NdC 13517-111-01 Manufactured for: e5 Pharma, LLC., Boca Raton, FL 33432 Cardinal Health Inc. Class II Terminated 20210602
PREGABALIN CAPSULES 300MG 90 ; NDC 43598-298-90; RX; CAPSULES Cardinal Health Inc. Class II Terminated 20210602
BENICAR 40MG 30; NDC/UPC 65597010430; RX; TABLETS Cardinal Health Inc. Class II Terminated 20210602
Iron 100 with Vitamin C Tablets Dietary Supplement 100 Tablets NDC 60258-099-01 Distributed By: Cypress Pharmaceutical, Inc. 135 Industrial Blvd. Madison, MS 39110 Cardinal Health Inc. Class II Terminated 20210602
Prilosec (Omeprazole Magnesium) For Delayed-Release Oral Suspension 10 mg Rx only NDC 70515-610-01 Mfd. for: Covis Pharma, Zug, 6300 Switzerland Cardinal Health Inc. Class II Terminated 20210602
CIPROFLOX/D5W 400/200 24X200ML; NDC/UPC 36000000924; RX; IV SOLUTION (PIGGYBACK) Cardinal Health Inc. Class II Terminated 20210602
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, FL 33156 Cardinal Health Inc. Class II Terminated 20210602
Meloxicam Tablets, USP 7.5 mg 100 Tablets Rx Only NDC 69097-158-07 Manufactured for: Cipla USA, Inc. 9100 S. Dadeland Blvd., Suite 1500 Miami, FL 33156 Cardinal Health Inc. Class II Terminated 20210602
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 50096-502-10 Manufactured for: Rosemar Labs, LLC 2100 West Loop South Suite 900 Houston, TX 77027 Cardinal Health Inc. Class II Terminated 20210602
Valsartan Tablets USP 40 mg 30 Scored Tablets Rx Only NDC 59746-360-30 Manufactured by: Jubilant Generics Ltd. Roorkee-247661, India Cardinal Health Inc. Class II Terminated 20210602
PRAVACHOL 40MG 90; NDC/UPC 3519410; RX; TABLETS Cardinal Health Inc. Class II Terminated 20210602
Synjardy XR (empagliflozin and metformin) hydrochloride extended-release) Tablets 12.5 mg/1000 mg 60 tablets Rx only NDC 0597-0300-45 Dist. by: Boehringer Ingelheim (BI) Pharmaceuticals, Inc. Ridgefield, CT 06877 USA Cardinal Health Inc. Class II Terminated 20210602
Synjardy XR (empagliflozin and metformin hydrochloride extended-release) Tablets 25 mg/1000 mg 30 tablets Rx only NDC 0597-0295-88 Dist. by: Boehringer Ingelheim (BI) Pharmaceuticals, Inc., Ridgefield, CT 06877 USA Cardinal Health Inc. Class II Terminated 20210602
Jentadueto XR (linagliptin and metformin hydrochloride extended-release) Tablets 5 mg/1000 mg 30 tablets Rx only NDC 0597-0275-33 Dist. by: Boehringer Ingleheim (BI) Pharmaceuticals, Inc. Ridgefield, CT 06877 USA Cardinal Health Inc. Class II Terminated 20210602
Synjardy (empagliflozin and metformin hydrochloride) Tablets 12.5 mg/1000 mg 60 tablets Rx only NDC 0597-0168-69 Distributed by: Boehringer Ingleheim (BI) Pharmaceuticals, Inc. Ridgefield, CT 06877 USA Cardinal Health Inc. Class II Terminated 20210602
Glyxambi (empagliflozin and linagliptin) Tablets 25 mg/5 mg 30 tablets Rx only NDC 0597-0164-30 Dist. by: Boehringer Ingelheim (BI) Pharmaceuticals, Inc. Ridgefield, CT 06877 USA Cardinal Health Inc. Class II Terminated 20210602
ATROVENT HFA 17MCG 12.9GM; NDC/UPC 597008717; RX; INHALER MEDICAL INTERNAL - MAY OR MAY NOT BE AEROSOL Cardinal Health Inc. Class II Terminated 20210602
Spiriva HandiHaler (tiotropium bromide inhalation powder) For Oral Inhalation Only 18 mcg (as tiotropium) per capsule Rx only NDC 0597-0075-41 Manufactured by: Boehringer Ingelheim (BI) Pharma GmbH & Co. KG Ingelheim, Germany Marketed by: Boehringer Ingelheim Pharmaceuticals, Inc. Ridgefield, CT 06877 USA and Pfizer, Inc. New York, NY 10017 USA Cardinal Health Inc. Class II Terminated 20210602
CATAPRES-TTS-2 1X4; NDC/UPC 597003234; RX; ADHESIVE PATCHES Cardinal Health Inc. Class II Terminated 20210602
NURTEC ODT (RIMEGEPANT) 75MG 8 BPK; NDC/UPC 72618-3000-2; RX; TABLETS FOR RAPID DISSOLUTION (NOT SUBLINGUAL) Cardinal Health Inc. Class II Terminated 20210602
SYMPROIC (NAIDEMEDINE) TABLETS 0.2MG 30 TABLETS; NDC 59385-041-30; RX; TABLETS Cardinal Health Inc. Class II Terminated 20210602
Belbuca (buprenorphine hydrochloride) buccal film 600 mcg 60 pouches containing 1 buccal film each Rx only NDC 59385-025-60 Manufactured for: BioDelivery Sciences International, Inc. Raleigh, NC 27612 USA Cardinal Health Inc. Class II Terminated 20210602
Belbuca (buprenorphine hydrochloride) buccal film 300 mcg 60 pouches containing 1 buccal film each Rx only NDC 59385-023-60 Manufactured for: BioDelivery Sciences International, Inc. Raleigh, NC 27612. Cardinal Health Inc. Class II Terminated 20210602
DEXAMETH SOD PHOS 0.1% 5ML; NDC/UPC 24208072002; RX; DROPS Cardinal Health Inc. Class II Terminated 20210602
TOBRAMY/DEX 0.3-0.1% 10ML OPTH; NDC/UPC 24208029510; RX; DROPS Cardinal Health Inc. Class II Terminated 20210602
MURO-128 2% 15ML OPTH; NDC/UPC 324208276150; OTC; DROPS Cardinal Health Inc. Class II Terminated 20210602
BENZEFOAM EMOLLIENT FOAM BENZOYL PEROXIDE 5.3% 100GM TOP EMOL NDC 187-0194--10; OTC; FOAMS Cardinal Health Inc. Class II Terminated 20210602
LOTEMAX SM (loteprednol etabonate ophthalmic gel) 0.38% 5GM; NDC/UPC 24208-0507-07; RX; GEL Cardinal Health Inc. Class II Terminated 20210602
Nuedexta (dextromethorphan HBr and quinidine sulfate) Capsules 20 mg/10 mg 60 capsules Rx only NDC 64597-301-60 Manufactured by Patheon, Inc. Whitby, ON L1N 5Z5, Canada Cardinal Health Inc. Class II Terminated 20210602
ESZOPICLONE 3MG 100 C4; NDC/UPC 65862096901; RX; TABLETS Cardinal Health Inc. Class II Terminated 20210602
ONDANSETRON HCL 4MG 30; NDC/UPC 65862018730; RX; TABLETS Cardinal Health Inc. Class II Terminated 20210602
AMOXICILLIN 500MG 100; NDC/UPC 65862001401; RX; TABLETS Cardinal Health Inc. Class II Terminated 20210602
Eletriptan Hydrobromide Tablets 20 mg* 6(1x6) Unit-dose Tablets Rx only NDC 59651-104-69 Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Highstown Road East Windsor, NJ 08520 Cardinal Health Inc. Class II Terminated 20210602
IBUPROFEN ORAL SUSPENSION USP 100MG/5ML 120ML ; NDC/UPC 59651-032-12; RX; SUSPENSION (NO DROPS) Cardinal Health Inc. Class II Terminated 20210602
xigduo XR (dapagliflozin/metformin HCl extended-release) tablets 5 mg/1000 mg 60 Tablets Rx only NDC 0310-6260-60 Manufactured for: AstraZeneca Pharmaceuticals LP Wilmington, DE 19850 Cardinal Health Inc. Class II Terminated 20210602
xigduo XR (dapgliflozin/metformin HCl extended-release) tablets 10 mg/1000 mg 30 Tablets Rx only NDC 0310-6280-30 Manufactured for: AstraZeneca Pharmaceuticals LP Wilmington, DE 19850 Manufactured by: Bristol-Myers Squibb Manufacturing Company Humacao, Puerto Rico 00791 Cardinal Health Inc. Class II Terminated 20210602
Bevespi Aerosphere (glycopyrrolate and formoterol fumarate) Inhalation Aerosol 9 mcg/4.8 mcg per inhalation For Oral Inhalation only 120 inhalations Rx Only NDC 0310-4600-12 Mfd for: AstraZeneca Pharmaceuticals, LP, Wilmington, DE 19850 Cardinal Health Inc. Class II Terminated 20210602
Brilinta ticagrelar tablets 60 mg 60 tablets Rx only NDC 0186-0776-60 Mfd. for: AstraZeneca LP, Wilmington, DE 19850 Cardinal Health Inc. Class II Terminated 20210602
GEMCITABINE INJECTION 200MG/5.26ML; NDC/UPC 72485-221-02; RX; SINGLEDOSE VIAL Cardinal Health Inc. Class II Terminated 20210602
edarbyclor Azilsartan Medoxomil and Chlorthalidone Tablets 40 mg*/25 mg *Each tablet contains: 42.68 mg azilsartan kamedoxomil (equivalent to 40 mg azilsartan medoxomil) and 25 mg chlorthalidone. 30 Tablets Rx Only NDC 60631-425-30 Manufactured for Arbor Pharmaceuticals Atlanta, GA 30328 Cardinal Health Inc. Class II Terminated 20210602
edarbyclor Azilsartan Medoxomil and Chlorthalidone Tablets 40 mg*/12.5 mg 30 Tablets Rx Only NDC 60631-412-30 Manufactured for: arbor Pharmaceuticals, LLC. Atlanta, GA 30328 Cardinal Health Inc. Class II Terminated 20210602
Edarbi (azilsartan medoxomil) tablets 80 mg 30 Tablets Rx Only NDC 60631-080-30 Manufactured for: arbor Pharmaceuticals Atlanta, GA 30328 Cardinal Health Inc. Class II Terminated 20210602
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: Apotex Inc. Toronto, Ontario Canada M9L 1T9 Manufactured for: Apotex Corp. Weston, FL 33326 Cardinal Health Inc. Class II Terminated 20210602
Butorphanol Tartrate Nasal Solution USP 10 mg/mL 2. 5 mL bottles Rx Only NDC 60505-0813-1 Mfg by: Apotex Inc. Toronto, Ontario Canada M9L 1T9 Cardinal Health Inc. Class II Terminated 20210602
ENOXAPARIN DOFIUM INJRVYION, UPD 150MG/1ML 10X1ML SINGLE DOSE SYRINGES; NDC/UPC 60505-0798-4; RX; SYRINGES Cardinal Health Inc. Class II Terminated 20210602
TRAVOPROST OPHTHALMIC SOLUTION, USP 0.004% 2.5ML ; NDC/UPC 60505-0593-4; RX; DROPS Cardinal Health Inc. Class II Terminated 20210602
ERYTHROMYCIN TABLETS, USP 250MG 30; NDC/UPC 69238-1484-3; RX; TABLETS Cardinal Health Inc. Class II Terminated 20210602