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
Minivelle (estradiol transdermal system) 0.0375 mg/day, 1 System per pouch (NDC 68968-6637-1), packaged in 8 pouches per box (NDC 68968-6637-8), Rx only, Mfd. by: Noven Pharmaceuticals, Inc., Miami, Florida 33186; Dist. by: Noven Therapeutics, LLC, Miami, Florida 33186. Noven Pharmaceuticals, Inc. Class II Terminated 20180516
Minivelle (estradiol transdermal system) 0.1 mg/day, 1 System per pouch (NDC 68968-6610-1), packaged in 8 pouches per box (NDC 68968-6610-8), Rx only, Mfd. by: Noven Pharmaceuticals, Inc., Miami, Florida 33186; Dist. by: Noven Therapeutics, LLC, Miami, Florida 33186. Noven Pharmaceuticals, Inc. Class II Terminated 20180516
OraVerse (Phentolamine Mesylate) Injection, 0.4 mg/1.7mL, packaged in a box of 10 cartridges of 0.4mg/1.7mL each, Rx only, Distributed by Septodont, Inc., Louisville, CO 80027, Made in Canada by Novocol Pharmaceutical of Canada, Inc., NDC 0362-0101-10 Septodont Inc. Class III Terminated 20180516
Macroaggregated albumin (MAA) kit (for the preparation of Tc99m MAA), Aggregated and non-Aggregated Human Serum Albumin 2.5-5 mg Sodium Acetate Sol 200 mL/0.125 mL lyophilized powder in 10 mL glass vial, Rx only, AnazaoHealth, Tampa, FL Coast Quality Pharmacy LLC Class II Terminated 20180516
Lupron Depot 22.5 mg 3 month Kit NDC 00074-3346-03 84 days supply Kroger Specialty Pharmacy, Inc. Class II Terminated 20180516
Kisqali 600 Dose 63 tablet 200 mg NDC 00078-0874-63 28 days supply Kroger Specialty Pharmacy, Inc. Class II Terminated 20180516
OPDIVO 40 mg/4 mL SDV NDC 00003-3772-11 28 days supply Kroger Specialty Pharmacy, Inc. Class II Terminated 20180516
Tasigna Capsules 150 mg NDC 00078-0592-87 28 days supply Kroger Specialty Pharmacy, Inc. Class II Terminated 20180516
Zarxio 300 mcg/0.5 mL PFS NDC 14 days supply Kroger Specialty Pharmacy, Inc. Class II Terminated 20180516
Perjeta 420 mg/14 mL SDV Vials 50242-0145-01 21 days supply Kroger Specialty Pharmacy, Inc. Class II Terminated 20180516
Letrozole 2.5 mg tab NDC 51991-0759-33 30 days supply Kroger Specialty Pharmacy, Inc. Class II Terminated 20180516
Ondansetron 8 mg tablet NDC 57237-0076-30 28 days supply Kroger Specialty Pharmacy, Inc. Class II Terminated 20180516
Bendeka 25 mg/mL 4 mL MDVPF NDC 63459-0348-04 28 days supply Kroger Specialty Pharmacy, Inc. Class II Terminated 20180516
Capecitabine 500 mg Tablet NDC 00378-2512-78 28 days supply and 21 days supply Kroger Specialty Pharmacy, Inc. Class II Terminated 20180516
Capecitabine 150 mg Tablet NDC 00378-2511-91 28 days supply Kroger Specialty Pharmacy, Inc. Class II Terminated 20180516
Imatinib Mesylate Tablet 400 mg NDC 60505-2901-03 30 days supply Kroger Specialty Pharmacy, Inc. Class II Terminated 20180516
Sutent 50 mg capsules x28 NDC 00069-0550-38 42 days supply Kroger Specialty Pharmacy, Inc. Class II Terminated 20180516
Sutent 37.5 mg capsules x28 NDC 00069-0830-38 28 days supply Kroger Specialty Pharmacy, Inc. Class II Terminated 20180516
Dexamethasone 4 mg tablet NDC 49884-0087-01 28 days supply Kroger Specialty Pharmacy, Inc. Class II Terminated 20180516
Cyclophosphamide 50 mg cap NDC 00054-0383-25 28 days supply Kroger Specialty Pharmacy, Inc. Class II Terminated 20180516
Sprycel 100 mg tablet NDC 00003-0852-22 30 days supply Kroger Specialty Pharmacy, Inc. Class II Terminated 20180516
Sprycel 80 mg tablet NDC 00003-0855-22 30 days supply Kroger Specialty Pharmacy, Inc. Class II Terminated 20180516
Gleevec 100 mg tablet NDC 00078-0401-34 30 days supply Kroger Specialty Pharmacy, Inc. Class II Terminated 20180516
Temozolomide 250 mg NDC 43975-0257-05 28 days supply Kroger Specialty Pharmacy, Inc. Class II Terminated 20180516
Temozolomide 20 mg NDC 43975-0253-05 28 days supply Kroger Specialty Pharmacy, Inc. Class II Terminated 20180516
Xalkori 250 mg cap NDC 00069-8140-20 30 days supply Kroger Specialty Pharmacy, Inc. Class II Terminated 20180516
Glatiramer Acetate 40 mg/mL NDC 00378-6961-12 28 days supply Kroger Specialty Pharmacy, Inc. Class II Terminated 20180516
Ibrance 125 mg cap NDC 00069-0189-21 28 days supply Kroger Specialty Pharmacy, Inc. Class II Terminated 20180516
Avonex 30 mcg/0.5 mL PFS Kit NDC 59627-0222-05 28 days supply Kroger Specialty Pharmacy, Inc. Class II Terminated 20180516
Revlimid 25 mg oral cap NDC 59572-0425-21 28 days supply Kroger Specialty Pharmacy, Inc. Class II Terminated 20180516
Revlimid 5 mg oral cap NDC 59572-0405-28 28 days supply Kroger Specialty Pharmacy, Inc. Class II Terminated 20180516
Revlimid 20 mg oral cap NDC 59572-0420-21 28 days supply Kroger Specialty Pharmacy, Inc. Class II Terminated 20180516
Revlimid 15 mg oral cap NDC 59572-0415-21 28 days supply Kroger Specialty Pharmacy, Inc. Class II Terminated 20180516
Revlimid 10 mg oral cap NDC 59572-0410-28 28 days supply Kroger Specialty Pharmacy, Inc. Class II Terminated 20180516
Promacta 50 mg tablet NDC 00078-0686-15 30 days supply Kroger Specialty Pharmacy, Inc. Class II Terminated 20180516
Xtandi 40 mg capsule NDC 00469-0125-99 30 days supply Kroger Specialty Pharmacy, Inc. Class II Terminated 20180516
Pomalyst 3 mg capsule NDC 59572-0503-21 28 days supply Kroger Specialty Pharmacy, Inc. Class II Terminated 20180516
Tecfidera 240 mg capsule NDC 64406-0006-02 30 days supply Kroger Specialty Pharmacy, Inc. Class II Terminated 20180516
Copaxone 20 mg Injection PFS (30) NDC 68546-0317-30 30 days supply. Kroger Specialty Pharmacy, Inc. Class II Terminated 20180516
Copaxone 40 mg Injection (12) NDC 68546-0325-12 28 days supply. Kroger Specialty Pharmacy, Inc. Class II Terminated 20180516
Praluent 75 mg Pen (2 pens/Pkg) NDC 00024-5901-02 28 days supply Kroger Specialty Pharmacy, Inc. Class II Terminated 20180516
Cimzia 200 mg/mL PFS Kit #2 NDC 50474-0710-79 28 days supply. Kroger Specialty Pharmacy, Inc. Class II Terminated 20180516
Stelara 90 mg/MI PFS NDC 57894-0061-03 84 days supply Kroger Specialty Pharmacy, Inc. Class II Terminated 20180516
Boost VHC Oral Liquid VAN #27 NDC 43900-0182-15 27 days supply Kroger Specialty Pharmacy, Inc. Class II Terminated 20180516
Dupixent 300 mg/2 mL PFS #2 w/ NS NDC 00024-5914-01 28 days supply Kroger Specialty Pharmacy, Inc. Class II Terminated 20180516
Vosevi 400/100/100 mg Tablets #28 NDC 61958-2401-01 28 days supply. Kroger Specialty Pharmacy, Inc. Class II Terminated 20180516
Xolair 150 mg SDV NDC 50242-0040-62 28 days Kroger Specialty Pharmacy, Inc. Class II Terminated 20180516
Sodium Chloride 3% Inh. 4 mL NEP #30 NDC 00487-9003-60 30 days supply. Kroger Specialty Pharmacy, Inc. Class II Terminated 20180516
MVW Complete Softgels NDC 58204-0004-00 30 days supply; MVW Complete Chew Vitamin Grape NDC 58204-0004-15 30 days supply. Kroger Specialty Pharmacy, Inc. Class II Terminated 20180516
Creon DR 24,000 Units Capsule #250 NDC 00032-1224-07 30 days supply Kroger Specialty Pharmacy, Inc. Class II Terminated 20180516