CARDINAL HEALTHCARE Recalls

42 recalls from federal safety databases (FDA, CPSC). Sourced directly from government enforcement feeds.

Drug Recalls (42)

January 26, 2022
RIVASTIGMINE TRANSDERMAL SYSTEM, Delivers 4.6 mg/24 hours, 30 systems per box, Rx Only, Distributed by: Alvogen, Inc., Morristown, NJ 07960. NDC 47781-304-03
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Class II
January 26, 2022
Inhub Wixela (fluticasone propionate and salmeterol inhalation powder, USP) 500/50MCG, 60 Doses of Inhalation Powder, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505. NDC: 0378-93
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Class II
January 26, 2022
Colgate Total SF Toothpaste, Net Wt 4.8 oz (136 g), Stannous Fluoride 0.454%, Clean Mint, Dist. by: COLGATE-PALMOLIVE CO., New York, NY 10022 USA
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Class II
January 26, 2022
Lillow (Levonorgestrel and Ethinyl Estradiol Tablets, USP), 0.15 mg/0.03 mg, 1 Blister Pack Containing 28 Tablets, Rx only, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807. NDC 6923
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Class II
January 26, 2022
Enoxaparin Sodium Injection, USP, 150MG/ML Single-Dose Syringes with Automatic Safety Device, For Subcutaneous Injection, Ten 1 mL Syringes per box, Rx Only, Sandoz Inc, Princeton, NJ 08540. NDC: 078
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Class II
January 26, 2022
Lithium Carbonate Extended-Release Tablets, USP, 300 mg, 100 Tablets per bottle, Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505. NDC: 0378-1300-01
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Class II
January 26, 2022
CHLORTHALIDONE Tablets, USP, 25MG, 1000 Tablets, Rx only, Manufactured by: Appco Pharma LLC, Piscataway, NJ 08854 USA; Manufactured For: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540 USA. NDC:
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Class II
January 26, 2022
Fluticasone Propionate Nasal Spray USP, 50MCG per spray, 16 g net fill weight, 120 Metered Sprays, For Intranasal Use Only, Rx Only, Manufactured for: Apotext Corp., Weston, FL 33326. NDC: 60505-0829
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Class II
January 26, 2022
Asmanex Twisthaler (mometasone furoate inhalation powder, 220 mcg per actuation), 120 Metered Doses, Rx only, Manufactured for: Organon LLC, a subsidiary of Organon & Co., Jersey City, NJ 07302; Manuf
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Class II
January 26, 2022
Meloxicam Tablets, USP, 15 mg, 1000 Tablets per bottle, Rx Only, Manufactured by: Cipla Ltd., Kurkumbh, India; Manufactured for: Cipla USA, Inc., 9100 S. Dadeland Blvd., Suite 1500 Miami, FL 33156. N
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Class II
January 26, 2022
ALBUTEROL SULFATE IN 90MCG per actuation, 200 Metered Inhalations, Rx Only, 8.5 g Net Contents, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202; Manufactured by: Lupin Limited
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Class II
January 26, 2022
Nyamyc, 100,000 USP units per gram, 60 grams, Rx only, Topical Use Only, Manufactured by: Upsher-Smith Laboratories, Inc, Minneapolis, MN 55447.
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Class II
January 26, 2022
Propranolol Hydrochloride Tablets, 20 mg, 100 Tablets per bottle, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Ahmedabad 382213, India; Distributed by: Amneal Pharmaceuticals LLC, Bridg
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Class II
January 26, 2022
Leader Nasal Decongestant PE (Phenylephrine HCl 10 mg), 18 Tablets per cartons, Distributed By Cardinal Health, Dublin, Ohio 43017. NDC: 70000-0126-1
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Class II
January 26, 2022
AMOXICILLIN Tablets, USP, 875MG, 20 Tablets, Rx Only, Manufactured by Sandoz GmbH for Sandoz Inc., Princeton, NJ 08540. NDC: 0781-5060-20
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Class II
January 26, 2022
ALLOPURINOL Tablets, USP 300 MG 500 count Tablets per bottle, Rx only, Manufactured By: Dr. Reddy's Laboratories LA LLC, Shreveport, LA 71106. NDC: 55111-730-05
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Class II
January 26, 2022
Warfarin Sodium Tablets, USP, 2.5 mg, 100 Tablets per bottle, Rx only, Manufactured For: Teva Pharmaceuticals, Parsippany, NJ 07054. NDC: 0093-1714-01
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Class II
January 26, 2022
SPIRIVA HANDIHALER (tiotropium bromide inhalation powder) 18 mcg/Capsule, 30 capsules, 3 blister cards, each card contains 10 capsules, Rx only, For oral inhalation only, Distributed by: Boehringer In
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Class II
January 26, 2022
ALBUTEROL SULFATE HFA Inhalation Aerosol, 90MCG per actuation, 200 Metered Inhalations, Net Wt. 18 g, Rx Only, Manufactured for: Prasco Laboratories, Mason, OH 45040 USA. NDC: 66993-019-68
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Class II
January 26, 2022
Warfarin Sodium Tablets, USP, 5 mg, 100 Tablets per bottle, Rx Only, Manufactured for: Teva Pharmaceuticals, Parsippany, NJ 07054. NDC: 0093-1721-01
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Class II
January 26, 2022
ARMOUR THYROID (thyroid tablets, USP), 2 GRAIN (120 mg), 100 Tablets, Rx Only, Distributed by: Allergan US, INc., Madison, NJ 07940. NDC: 0456-0461-01
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Class II
January 26, 2022
Donepezil HCl Tablets, 5 mg, 90 Tablets, Rx only, Distributed by: Solco Healthcare U.S. LLC, Hurracao, Puerto Rico 00791. NDC: 43547-275-09
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Class II
January 26, 2022
Triamterene and Hydrochlorothiazide Capsules, USP, 37.5 mg/25 mg, 100 capsules per bottle, Rx Only, Distributed by: Lannett Company, Inc, Philadelphia, PA 19136. NDC 0527-1632-01
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Class II
January 26, 2022
FIRST LANSOPRAZOLE PT 3MG/ML, 300ML, Rx Only, Distributed By: CutisPharma, Inc., Woburn, MA 01801. NDC: 65628-080-10
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Class II
January 26, 2022
Donepezil HCl Tablets, 10 mg, 90 Tablets, Rx only, Distributed by: Solco Healthcare U.S. LLC, Hurracao, Puerto Rico 00791. NDC: 43547-276-09
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Class II
January 26, 2022
Low Dose ASPIRIN, 81 mg, 120 Enteric Coated Tablets, Distributed by: Rugby Lavoratories, 17177 N Laurel Park Drive, Suite 233, Livonia, MI 48152. NDC: 0536-1234-41
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Class II
January 26, 2022
Bumetanide Tablets, USP, 2 mg, 100 Tablets per bottle, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Ahmedabad 382213 India; Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 0
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Class II
January 26, 2022
ESTRADIOL TABLETS USP, 0.5MG 100 Tablets, Tx Only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454. NDC: 0555-0899-02
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Class II
January 26, 2022
Doxycycline Capsules, USP 100 mg, 50 Capsules, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202 Unite States; Manufactured by: Lupin Limited, Nagpur - 441 108, INDIA.
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Class II
January 26, 2022
Lisinopril and Hydrochlorothiazide Tablets USP, 10mg/12.5mg, Rx only, 100 Tablets per bottles, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202; Manufactured by: Lupin Limited,
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Class II
January 26, 2022
Terconazole Vaginal Suppositories, 80 mg, 3 Suppositories with Vaginal Applicator, Rx only, Manufactured by: Cosette Pharmaceuticals, Inc., 111 Coolidge Street, South Plainfield, NJ 07080. NDC: 0713
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Class II
January 26, 2022
HydrALAZINE Hydrochloride Tablets, USP, 25 mg, 100 Tablets per bottle, Rx only, Distributed by: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816. NDC: 23155-002-01
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Class II
January 26, 2022
Aripiprazole Tablets, USP, 5 mg, 30 Tablets per bottle, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807. NDC: 65162-897-03
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Class II
January 26, 2022
PredniSONE Tablets, USP, 20 mg, 100 Tablets per bottle, Rx Only, Manufactured by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801. NDC: 59746-175-06
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Class II
January 26, 2022
Metoprolol Succinate Extended-Release Tablets, USP, 50 mg, 1000 Tablets, Rx Only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454. NDC: 45963-676-96
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Class II
January 26, 2022
AMOXICILLIN for Oral Suspension USP, 400MG/5ML, 100ML (when reconstituted), Manufactured In Canada By: TEVA CANA LIMITED, Toronto, Canada M1B 2K9; Manufactured For: TEVA PHARMACEUTICALS USA, INC., Nor
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Class II
January 26, 2022
Ricola CherryHoney Herb Throat Drops (menthol, 1.8 mg), 10 Drops per roll, Manufacturer: Ricola Ltd., 4242 Laufen, Switzerland; Distributed by: Ricola USA Inc., 6 Campus Drive, 2nd Floor South, Parsip
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Class II
January 26, 2022
Ipratropium Bromide and Albuterol Sulfate Inhalation Solution (0.5 mg/3 mg per 3 mL), 60 x 3 mL Sterile Unit-Dose Vials (2 pouches of 30 - 3 mL vials each), Manufactured By: The Ritedose Corporation,
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Class II
January 26, 2022
Dicyclomine Hydrochloride Tablets, USP 20 mg, 100 Tablets, Rx only, Manufactured For: Teva Pharmaceuticals USA, Parsippany, NJ 07054. NDC: 0591-0795-01
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Class II
January 26, 2022
Jardiance (empagliflozin tablets), 25 mg, 30 tablets (3 blister cards with 10 tablets each), Rx only, Distributed by: Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT 06877. NDC: 0597-0153-
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Class II
January 26, 2022
CITALOPRAM Tablets, USP, 20MG, 100 Tablets, Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 USA. NDC: 0378-6232-01
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Class II
January 26, 2022
FOLIC ACID TABLETS, USP, 1MG, 100 Tablets per bottle, Rx Only, Manufactured by: Leading Pharma, LLC, Fairfield, NJ 07004. NDC: 69315-127-10
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Class II

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.