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Unrated Drug recall · FDA · Published April 3, 2018

Kroger Specialty Pharmacy recalls Sutent capsules due to processing controls issue

Kroger Specialty Pharmacy recalls Sutent 50mg capsules (NDC 00069-0550-38) with 42-day supply due to lack of processing controls. Affected units dispensed between Dec 2017 and Feb 2018.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-0788-2018DrugKroger Specialty Pharmacy ›
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Contact the company

Recalling firmKroger Specialty Pharmacy, Inc.100 Pear Orchard Dr Ste A · Vicksburg, MS 39180-7153
✎ GovInfoNow plain-language explainer

What happened, in plain English

Kroger Specialty Pharmacy is recalling Sutent 50 mg capsules (28-count, 42-day supply) because of processing control issues. This could affect patients taking the medication as part of their treatment plan. Read more at govinfonow.com/recall/40651-kroger-specialty-pharmacy-recalls-sutent-capsules-due-to-processing-controls.

Source Summary by GovInfoNow · govinfonow.com/recall/40651-kroger-specialty-pharmacy-recalls-sutent-capsules-due-to-processing-controls · Updated September 23, 2026 · FDA enforcement record: FDA #D-0788-2018

Cite this page

“Kroger Specialty Pharmacy recalls Sutent capsules due to processing controls issue.” GovInfoNow, updated September 23, 2026. https://govinfonow.com/recall/40651-kroger-specialty-pharmacy-recalls-sutent-capsules-due-to-processing-controls. Based on FDA recall #D-0788-2018 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0788-2018%22&limit=1).

Why it’s dangerous

The recall is due to a lack of processing controls, which could lead to medication errors or inconsistencies in the product. However, the exact risk to patients is not clearly described in the recall notice.

Who’s affected

Patients prescribed Sutent 50 mg capsules with NDC 00069-0550-38 who received the medication between December 1, 2017 and February 12, 2018. Those with the specific product code are most at risk.

How to tell if you have this one

Check for the product name 'Sutent 50 mg capsules', NDC code 00069-0550-38, and a 28-count supply. The medication was dispensed between December 1, 2017 and February 12, 2018.

  • Brand
    Kroger Specialty Pharmacy
  • Category
    Drug
FDA recall event · 67 products

All 67 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Terminated
  • Distribution
    MS, LA, AR, IL, FL
Recall numberProduct, codes & lotsQuantity
D-0734-2018Humira Pen Sub-q Kit a.) 40 mg/0.8 mL (NDC 00074-4339-02); Humira Pen Psor Kit b.) 40 mg/0.8 mL (NDC 00074-4339-07) 28 day supply, Rx Only,; All lots remaining within expiry dispensed 12/01/2017 through 02/12/2018Unknown
D-0735-2018Albuterol 0.083% Inh Sol. 30 days supply, Rx Only, 39183, NDC 76204-0200-60, 30; All lots remaining within expiry dispensed 12/01/2017 through 02/12/2018Unknown
D-0736-2018Kalydeco 150 mg tablet blister, 28 days supply, Rx Only, 39183, NDC 51167-0200-01; All lots remaining within expiry dispensed 12/01/2017 through 02/12/2018Unknown
D-0737-2018Pediasure Liq. Vanilla G+G (CAN) #24 24 days supply, NDC 70074-0558-98; All lots remaining within expiry dispensed 12/01/2017 through 02/12/2018Unknown
D-0738-2018Polyethylene Glycol 3350, powder, for solution 527g BRE, Rx Only, 28 days supply, NDC 51991-0457-57; All lots remaining within expiry dispensed 12/01/2017 through 02/12/2018Unknown
D-0739-2018Pulmicort Respules 0.5 mg/2mL s, 30 days supply, NDC 00186-1989-04; All lots remaining within expiry dispensed 12/01/2017 through 02/12/2018Unknown
D-0740-2018Otezla 30 mg tablet NDC 59572-0631-06 30 days supply;; All lots remaining within expiry dispensed 12/01/2017 through 02/12/2018Unknown
D-0741-2018Taltz 80 mg/mL Pen 1-pk NDC 00002-1445-11 28 days supply; All lots remaining within expiry dispensed 12/01/2017 through 02/12/2018Unknown
D-0742-2018Cosentyx 150 mg/mL PFS 300 mg Dose NDC 00078-0639-98, 28 days supply; All lots remaining within expiry dispensed 12/01/2017 through 02/12/2018Unknown
D-0743-2018Altera Handset NDC 83490-0678-05 56 days supply; All lots remaining within expiry dispensed 12/01/2017 through 02/12/2018Unknown
D-0744-2018Cayston 75 mg Inh. Soln. SDV NDC 61958-0901-01 56 days supply; All lots remaining within expiry dispensed 12/01/2017 through 02/12/2018Unknown
D-0745-2018Repatha 140 mg/mL Sureclick AI 2-pk NDC 55513-0760-02 28 days supply; All lots remaining within expiry dispensed 12/01/2017 through 02/12/2018Unknown
D-0746-2018Enbrel PFS 50 mg/mL Inj #4 NDC 58406-0435-04 28 days supply;; All lots remaining within expiry dispensed 12/01/2017 through 02/12/2018Unknown
D-0747-2018Botox 100 Units Vial NDC 00023-1145-01 90 days supply.; All lots remaining within expiry dispensed 12/01/2017 through 02/12/2018Unknown
D-0748-2018Prolia 60 mg/1 mL PF syringe NDC 55513-0710-01 180 days supply.; All lots remaining within expiry dispensed 12/01/2017 through 02/12/2018Unknown
D-0749-2018Kitabis Pak 300 mg/5 mL Soln PARI #56 NDC 24492-0850-56 56 days supply; All lots remaining within expiry dispensed 12/01/2017 through 02/12/2018Unknown
D-0750-2018Orkambi 200 mg/125 mg Tablets #112 NDC 51167-0809-01 28 days supply.; All lots remaining within expiry dispensed 12/01/2017 through 02/12/2018Unknown
D-0751-2018Orkambi 100 mg/125 mg Tablets #112 NDC 51167-0700-02 28 days supply.; All lots remaining within expiry dispensed 12/01/2017 through 02/12/2018Unknown
D-0752-2018Bethkis 300 mg/4 mL Ampule #56 NDC 10122-0820-56 56 days supply; All lots remaining within expiry dispensed 12/01/2017 through 02/12/2018Unknown
D-0753-2018Pulmozyme 1 mg/mL Inh. Soln. #30 NDC 50242-0100-40 30 days supply.; All lots remaining within expiry dispensed 12/01/2017 through 02/12/2018Unknown
D-0754-2018Azithromycin 250 mg tablet #18 TEV NDC 50111-0787-66 28 days supply; All lots remaining within expiry dispensed 12/01/2017 through 02/12/2018Unknown
D-0755-2018Creon DR 24,000 Units Capsule #250 NDC 00032-1224-07 30 days supply; All lots remaining within expiry dispensed 12/01/2017 through 02/12/2018Unknown
D-0756-2018MVW Complete Softgels NDC 58204-0004-00 30 days supply; MVW Complete Chew Vitamin Grape NDC 58204-0004-15 30 days supply.; All lots remaining within expiry dispensed 12/01/2017 through 02/12/2018N/A
D-0757-2018Sodium Chloride 3% Inh. 4 mL NEP #30 NDC 00487-9003-60 30 days supply.; All lots remaining within expiry dispensed 12/01/2017 through 02/12/2018Unknown
D-0758-2018Xolair 150 mg SDV NDC 50242-0040-62 28 days; All lots remaining within expiry dispensed 12/01/2017 through 02/12/2018Unknown
D-0759-2018Vosevi 400/100/100 mg Tablets #28 NDC 61958-2401-01 28 days supply.; All lots remaining within expiry dispensed 12/01/2017 through 02/12/2018Unknown
D-0760-2018Dupixent 300 mg/2 mL PFS #2 w/ NS NDC 00024-5914-01 28 days supply; All lots remaining within expiry dispensed 12/01/2017 through 02/12/2018Unknown
D-0761-2018Boost VHC Oral Liquid VAN #27 NDC 43900-0182-15 27 days supply; All lots remaining within expiry dispensed 12/01/2017 through 02/12/2018Unknown
D-0762-2018Stelara 90 mg/MI PFS NDC 57894-0061-03 84 days supply; All lots remaining within expiry dispensed 12/01/2017 through 02/12/2018Unknown
D-0763-2018Cimzia 200 mg/mL PFS Kit #2 NDC 50474-0710-79 28 days supply.; All lots remaining within expiry dispensed 12/01/2017 through 02/12/2018Unknown
D-0764-2018Praluent 75 mg Pen (2 pens/Pkg) NDC 00024-5901-02 28 days supply; All lots remaining within expiry dispensed 12/01/2017 through 02/12/2018Unknown
D-0765-2018Copaxone 40 mg Injection (12) NDC 68546-0325-12 28 days supply.; All lots remaining within expiry dispensed 12/01/2017 through 02/12/2018Unknown
D-0766-2018Copaxone 20 mg Injection PFS (30) NDC 68546-0317-30 30 days supply.; All lots remaining within expiry dispensed 12/01/2017 through 02/12/2018Unknown
D-0767-2018Tecfidera 240 mg capsule NDC 64406-0006-02 30 days supply; All lots remaining within expiry dispensed 12/01/2017 through 02/12/2018Unknown
D-0768-2018Pomalyst 3 mg capsule NDC 59572-0503-21 28 days supply; All lots remaining within expiry dispensed 12/01/2017 through 02/12/2018Unknown
D-0769-2018Xtandi 40 mg capsule NDC 00469-0125-99 30 days supply; All lots remaining within expiry dispensed 12/01/2017 through 02/12/2018Unknown
D-0770-2018Promacta 50 mg tablet NDC 00078-0686-15 30 days supply; All lots remaining within expiry dispensed 12/01/2017 through 02/12/2018Unknown
D-0771-2018Revlimid 10 mg oral cap NDC 59572-0410-28 28 days supply; All lots remaining within expiry dispensed 12/01/2017 through 02/12/2018Unknown
D-0772-2018Revlimid 15 mg oral cap NDC 59572-0415-21 28 days supply; All lots remaining within expiry dispensed 12/01/2017 through 02/12/2018Unknown
D-0773-2018Revlimid 20 mg oral cap NDC 59572-0420-21 28 days supply; All lots remaining within expiry dispensed 12/01/2017 through 02/12/2018Unknown
D-0774-2018Revlimid 5 mg oral cap NDC 59572-0405-28 28 days supply; All lots remaining within expiry dispensed 12/01/2017 through 02/12/2018Unknown
D-0775-2018Revlimid 25 mg oral cap NDC 59572-0425-21 28 days supply; All lots remaining within expiry dispensed 12/01/2017 through 02/12/2018Unknown
D-0776-2018Avonex 30 mcg/0.5 mL PFS Kit NDC 59627-0222-05 28 days supply; All lots remaining within expiry dispensed 12/01/2017 through 02/12/2018Unknown
D-0777-2018Ibrance 125 mg cap NDC 00069-0189-21 28 days supply; All lots remaining within expiry dispensed 12/01/2017 through 02/12/2018Unknown
D-0778-2018Glatiramer Acetate 40 mg/mL NDC 00378-6961-12 28 days supply; All lots remaining within expiry dispensed 12/01/2017 through 02/12/2018Unknown
D-0779-2018Xalkori 250 mg cap NDC 00069-8140-20 30 days supply; All lots remaining within expiry dispensed 12/01/2017 through 02/12/2018Unknown
D-0780-2018Temozolomide 20 mg NDC 43975-0253-05 28 days supply; All lots remaining within expiry dispensed 12/01/2017 through 02/12/2018Unknown
D-0781-2018Temozolomide 250 mg NDC 43975-0257-05 28 days supply; All lots remaining within expiry dispensed 12/01/2017 through 02/12/2018Unknown
D-0782-2018Gleevec 100 mg tablet NDC 00078-0401-34 30 days supply; All lots remaining within expiry dispensed 12/01/2017 through 02/12/2018Unknown
D-0783-2018Sprycel 80 mg tablet NDC 00003-0855-22 30 days supply; All lots remaining within expiry dispensed 12/01/2017 through 02/12/2018Unknown
D-0784-2018Sprycel 100 mg tablet NDC 00003-0852-22 30 days supply; All lots remaining within expiry dispensed 12/01/2017 through 02/12/2018Unknown
D-0785-2018Cyclophosphamide 50 mg cap NDC 00054-0383-25 28 days supply; All lots remaining within expiry dispensed 12/01/2017 through 02/12/2018Unknown
D-0786-2018Dexamethasone 4 mg tablet NDC 49884-0087-01 28 days supply; All lots remaining within expiry dispensed 12/01/2017 through 02/12/2018Unknown
D-0787-2018Sutent 37.5 mg capsules x28 NDC 00069-0830-38 28 days supply; All lots remaining within expiry dispensed 12/01/2017 through 02/12/2018Unknown
D-0788-2018Sutent 50 mg capsules x28 NDC 00069-0550-38 42 days supply; All lots remaining within expiry dispensed 12/01/2017 through 02/12/2018Unknown
D-0789-2018Imatinib Mesylate Tablet 400 mg NDC 60505-2901-03 30 days supply; All lots remaining within expiry dispensed 12/01/2017 through 02/12/2018Unknown
D-0790-2018Capecitabine 150 mg Tablet NDC 00378-2511-91 28 days supply; All lots remaining within expiry dispensed 12/01/2017 through 02/12/2018Unknown
D-0791-2018Capecitabine 500 mg Tablet NDC 00378-2512-78 28 days supply and 21 days supply; All lots remaining within expiry dispensed 12/01/2017 through 02/12/2018Unknown
D-0792-2018Bendeka 25 mg/mL 4 mL MDVPF NDC 63459-0348-04 28 days supply; All lots remaining within expiry dispensed 12/01/2017 through 02/12/2018Unknown
D-0793-2018Ondansetron 8 mg tablet NDC 57237-0076-30 28 days supply; All lots remaining within expiry dispensed 12/01/2017 through 02/12/2018Unknown
D-0794-2018Letrozole 2.5 mg tab NDC 51991-0759-33 30 days supply; All lots remaining within expiry dispensed 12/01/2017 through 02/12/2018Unknown
D-0795-2018Perjeta 420 mg/14 mL SDV Vials 50242-0145-01 21 days supply; All lots remaining within expiry dispensed 12/01/2017 through 02/12/2018Unknown
D-0796-2018Zarxio 300 mcg/0.5 mL PFS NDC 14 days supply; All lots remaining within expiry dispensed 12/01/2017 through 02/12/2018Unknown
D-0797-2018Tasigna Capsules 150 mg NDC 00078-0592-87 28 days supply; All lots remaining within expiry dispensed 12/01/2017 through 02/12/2018Unknown
D-0798-2018OPDIVO 40 mg/4 mL SDV NDC 00003-3772-11 28 days supply; All lots remaining within expiry dispensed 12/01/2017 through 02/12/2018Unknown
D-0799-2018Kisqali 600 Dose 63 tablet 200 mg NDC 00078-0874-63 28 days supply; All lots remaining within expiry dispensed 12/01/2017 through 02/12/2018Unknown
D-0800-2018Lupron Depot 22.5 mg 3 month Kit NDC 00074-3346-03 84 days supply; All lots remaining within expiry dispensed 12/01/2017 through 02/12/2018Unknown
Based on the official FDA remedy

What to do — step by step

  1. Check Your Medication

    Verify if you have Sutent 50 mg capsules with NDC 00069-0550-38 that were dispensed between December 1, 2017 and February 12, 2018.

Where it went and when

Where it was distributed

Distributed in 5 states.

Alaska: not listedAKMaine: not listedMEVermont: not listedVTNew Hampshire: not listedNHWashington: not listedWAIdaho: not listedIDMontana: not listedMTNorth Dakota: not listedNDMinnesota: not listedMNIllinois: yesILWisconsin: not listedWIMichigan: not listedMINew York: not listedNYRhode Island: not listedRIMassachusetts: not listedMAOregon: not listedORNevada: not listedNVWyoming: not listedWYSouth Dakota: not listedSDIowa: not listedIAIndiana: not listedINOhio: not listedOHPennsylvania: not listedPANew Jersey: not listedNJConnecticut: not listedCTCalifornia: not listedCAUtah: not listedUTColorado: not listedCONebraska: not listedNEMissouri: not listedMOKentucky: not listedKYWest Virginia: not listedWVVirginia: not listedVAMaryland: not listedMDDelaware: not listedDEArizona: not listedAZNew Mexico: not listedNMKansas: not listedKSArkansas: yesARTennessee: not listedTNNorth Carolina: not listedNCSouth Carolina: not listedSCDistrict of Columbia: not listedDCOklahoma: not listedOKLouisiana: yesLAMississippi: yesMSAlabama: not listedALGeorgia: not listedGAHawaii: not listedHITexas: not listedTXFlorida: yesFL

FDA distribution: “MS, LA, AR, IL, FL” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Arkansas, Florida, Illinois, Louisiana, Mississippi.

Recall timeline

FDA terminated this recall 2.1 years after the firm started it.

1. Firm started the recall: Apr 3, 201812. FDA classified it Class II: May 10, 201823. Published in FDA’s Enforcement Report: May 16, 201834. FDA terminated the recall: May 7, 2020420182020
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Keep exploring

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #D-0788-2018 (April 3, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0788-2018 to see it in context.
  • Plain-language summary written by qwen3:4b on September 23, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA