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 141–160 of 1,000 recalls

Class IIIOngoing

Abilify (aripiprazole), 10 mg tablets, packaged in a) 30 count bottles (NDC 59148-008-13) and b) 7 count blister packs (NDC 59148-008-95), RX only, Otsuka America Pharmaceutical, Inc.

Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd.

Cross Contamination with Other Products

April 9, 2024 · DrugView details →

Class IIIOngoing

Abilify (aripiprazole), 30 mg tablets, packaged in 30 count bottles, RX only, Otsuka America Pharmaceutical, Inc., NDC 59148-011-13

Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd.

Cross Contamination with Other Products

April 9, 2024 · DrugView details →

Cyclophosphamide for Injection, USP, 1g/vial, Lyophilized, Single Dose Vial, Discard unused solution, Cytotoxic Agent, After Reconstitution: For direct intravenous injection or must be further diluted before intravenous infusion, Rx Only, Manufactured for: XGen Pharmaceuticals DJB, Inc., Big Flats, NY 14814, NDC # 39822-0255-01.

Labeling: Incorrect or missing Package Insert: There is an error on the Package Insert (PI), section 2.3, Preparation, Handling, and Administration. The concentration of the reconstituted product is listed as '20 mg per vial.' This information should read: '20 mg per mL'.

FDA Drug Recalls

Abilify (aripiprazole), 10 mg tablets, packaged in a) 30 count bottles (NDC 59148-008-13) and b) 7 count blister packs (NDC 59148-008-95), RX only, Otsuka America Pharmaceutical, Inc.

Abilify (aripiprazole), 30 mg tablets, packaged in 30 count bottles, RX only, Otsuka America Pharmaceutical, Inc., NDC 59148-011-13

Cyclophosphamide for Injection, USP, 500mg/vial, Lyophilized, Cytotoxic Agent, Single Dose Vial for Intravenous Use, Rx Only, Manufactured for: XGen Pharmaceuticals DJB, Inc. Big Flats, NY 14814, NDC # 39822-0250-01.

NEXLIZET (bempedoic acid and ezetimibe) tablets, 180 mg/10 mg, 30-count bottle, Rx only, Manufactured for: Esperion Therapeutics, Ann Arbor, MI 48108, NDC 72426-818-03

Digoxin Tablets, USP 62.5 mcg (0.0625 mg), 100-count bottles, Rx Only, Manufactured by: Novitium Pharma LLC, 70 Lake Drive, East Windsor, New Jersey 08520, NDC 70954-200-10

Digoxin Tablets, USP 125mcg, (0.125 mg), 1000-count bottle, Rx Only, Manufactured by: Novitium Pharma LLC., 70 Lake Drive, East Windsor, New Jersey 08520, NDC 70954-201-20

Clindamycin Phosphate, Topical Solution USP, 1%, 60 mL, Rx Only, Manufactured for and Distributed by: Marlex Pharmaceuticals, Inc., New Castle, DE 19720, NDC 10135-0691-61

Clindamycin Phosphate Topical Solution USP, 1%, 60 mL bottle, Manufactured for: Glasshouse Pharmaceuticals Limited Canada, Mississauga, Ontario, Canada, L5N 6R8, NDC 71428-0003-60

Mercaptopurine Tablets, USP 50 mg, packaged in: a) 25-count bottle (NDC 69076-913-02), b) 250-count bottle (NDC 69076-913-25), Rx only, Manufactured for: Quinn Pharmaceuticals, Boca Raton, FL, www.quinnrx.com

HydrALAZINE Hydrochloride Tablets, USP, 10 mg, 100-count (10 x 10) per unit dose carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC Carton: 68084-447-01; NDC Unit Dose: 68084-447-11

Nortrel (norethindrone and ethinyl estradiol tablets USP) 0.5/35, packaged in cartons, each carton contains 3 blister cards, each card contains 28 tablets, Rx only, TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, NDC 0555-9008-67

Nortrel 7/7/7 (norethindrone and ethinyl estradiol tablets USP- triphasic regimen), packaged in cartons, each carton contains 6 blister cards, each card contains 28 tablets, Rx only, TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, NDC 0555-9012-58

Glimepiride Tablets, USP 1mg, 500-count bottles, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakulam-532 409 INDIA, NDC: 55111-320-05

Glimepiride Tablets, USP 1mg, 100-count bottles, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakulam-532 409 INDIA, NDC: 55111-320-01

Benzonatate Capsules, USP, 100 mg, 100 Capsules (10 capsules x 10 unit dose cards), Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217. Carton NDC 68084-214-01; Individual Dose NDC 68084-214-11

ANORO ELLIPTA (umeclidinium and vilanterol inhalation powder) 62.5 mcg/25mcg. 1 inhaler contains 30 doses (60 blisters total), Rx Only, Manufactured by GlaxoSmithKline Durham, NC 27701. NDC 0173-0869-10

Eprontia (topiramate) oral solution, 25 mg/mL, 473 mL Bottle, Rx only, Manufactured for: Azurity Pharmaceuticals, Woburn, MA 01801, NDC 52652-9001-1

buPROPion Hydrochloride Extended-Release Tablets, USP (SR) 200 mg, 60 Tablets bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited, Halol-Baroda Highway, Halol-389 350, Gujarat, India NDC 47335-738-86

Votrient (pazopanib) 200 mg tablets, 120-count bottle, Rx Only, Manufactured by: Siegried Barbera, S.L., Barbera del Valles, Spain, Distributed by: Novartis Pharmaceuticals Corp., East Hanover, N.J. 07936, NDC 0078-1077-66