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FDA Recalls
›Drug Recalls

FDA Drug Recalls

Recalls of prescription drugs, over-the-counter medications, and compounded pharmaceuticals.

Classification

All Class I Class II Class III

Status

All Ongoing Completed Terminated

Date

All time Past 30 days Past 12 months

Showing 5181–5200 of 17,755 recalls

Class IITerminated

Balziva 28 Day (norethindrone and ethinyl estradiol tablets USP) 6 Blister Card Dispensers, 28 tablets each, Rx Only, Manufactured for: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0555-9034-58

Cardinal Health Inc.

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

March 15, 2021 · DrugView details →

Class IITerminated

HYDROCORTISONE 1% 30gm cream

Cardinal Health Inc.

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

March 15, 2021 · DrugView details →

Class IITerminated

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.

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

March 15, 2021 · DrugView details →

Class IITerminated

Amantadine Hydrochloride Tablets 100 mg 100-count bottle, Rx Only Manufactured by Upsher-Smith Laboratories, Inc. Maple Grove, MN 55369, NDC 0832-0111-00

Cardinal Health Inc.

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

March 15, 2021 · DrugView details →

Class IITerminated

HySept Solution 0.25% Sodium Hypochlorite Solution 473 mL (16 fl. oz.) NDC 39328-063-25 Manufactured in USA Patrin Pharma, Skokie, IL 60076

Cardinal Health Inc.

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

March 15, 2021 · DrugView details →

Class IITerminated

TRAVOPROST OPHTHALMIC SOLUTION, USP 0.004% 2.5ML ; NDC/UPC 60505-0593-4; RX; DROPS

Cardinal Health Inc.

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

March 15, 2021 · DrugView details →

Class IITerminated

Trokendi XR (topiramate) extended-release capsules 100 mg 30 Capsules Rx only, Manufactured by: Catalent Pharma Solutions Winchester, KY 40391 USA Manufactured for: Supernus Pharmaceuticals, Inc. Rockville, MD 20850 USA, NDC 17772-103-30

Cardinal Health Inc.

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

March 15, 2021 · DrugView details →

Class IITerminated

TOBREX 0.3% 3.5GM OPTH; NDC/UPC 65064435; RX; OINTMENT

Cardinal Health Inc.

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

March 15, 2021 · DrugView details →

Class IITerminated

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.

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

March 15, 2021 · DrugView details →

Class IITerminated

PENICILLIN V POT for Oral Solution, USP 125mg/5mL 100mL (when mixed) Rx Only, Manufactured for: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0093-4125-73

Cardinal Health Inc.

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

March 15, 2021 · DrugView details →

Class IITerminated

BENZOYL PEROXIDE WASH 5% 148ML; NDC/UPC 0536-1259-63; OTC; LIQUID

Cardinal Health Inc.

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

March 15, 2021 · DrugView details →

Class IITerminated

TRI-LO-MARZIA 0.180MG/0.025MG; 0.215 MG/0.025MG AND 0.250MG/0.025MG 3X28 BPK; NDC/UPC 68180-837-73; RX; TABLETS

Cardinal Health Inc.

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

March 15, 2021 · DrugView details →

Class IITerminated

Synthroid (levothyroxine sodium tablets, USP) in all pack sizes, styles and concentrations Rx only Abbott Laboratories North Chicago, IL

Cardinal Health Inc.

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

March 15, 2021 · DrugView details →

Class IITerminated

BUPRENORPHINE AND NALOXONE SUBLINGUAL FILM 4MG/1MG 30 POUCHES EACH CONTAINING 1 SUBLINGUAL FILM NDC/UPC 47781-0356-03; RX; FILM

Cardinal Health Inc.

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

March 15, 2021 · DrugView details →

Class IITerminated

COSOPT (Dorzolamide Hydrochloride-Timolol Maleate Ophthalmic Solution) (Dorzolamide Hydrochloride 22.3 mg/mL Timolol Maleate 6.8 mg/mL) 10ML Ocumeter Plus Ophthalmic Dispenser Sterile Ophthlamic Solution Rx only NDC/UPC 174780-605-10 Distributed by: Akorn, Inc. Lake Forest, IL 60045

Cardinal Health Inc.

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

March 15, 2021 · DrugView details →

Class IITerminated

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.

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

March 15, 2021 · DrugView details →

Class IITerminated

VITAMIN D3 50MCG 100 SOFTGELS; NDC/UPC 880681009000; OTC; GELCAP

Cardinal Health Inc.

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

March 15, 2021 · DrugView details →

Class IITerminated

Levothyroxine Sodium Tablets, USP 125 mcg (0.125 mg) 90 Tablets Rx only NDC 0378-1813-77 Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.

Cardinal Health Inc.

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

March 15, 2021 · DrugView details →

Class IITerminated

Banophen Diphenhydramine HCl 25 mg Antihistamine 100 capsules NDC 0904-5306-60 Distributed by: Major Pharmaceuticals 31778 Enterprise Drive Livonia, MI 48150 USA

Cardinal Health Inc.

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

March 15, 2021 · DrugView details →

Class IITerminated

Budesonide and Formoterol Fumarate Dihydrate Inhalation Aerosol 80/4.5 budesonide 80 mcg/formoterol fumarate dihydrate 4.5 mcg Inhalation Aerosol 120 inhalations Rx only Manufactured for: AstraZeneca Pharmaceuticals LP, Wilmington, DE 19850, NDC 0310-7372-20

Cardinal Health Inc.

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

March 15, 2021 · DrugView details →

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