thejoe Kroger Specialty Pharmacy, Inc.

Kroger Specialty Pharmacy, Inc.: 67 FDA recall reports

Every drug recall the FDA has published for Kroger Specialty Pharmacy, Inc.. The fault, and how the agency graded it.

67Reports

0Class I

0Ongoing

2018-05-16Most recent

What the classes mean

The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.

Class	What the FDA is saying
Class I	There is a reasonable probability that using this will cause serious harm or death.
Class II	It may cause temporary or reversible harm. Serious harm is unlikely.
Class III	It breaks a rule but is unlikely to hurt anyone. Often a labelling fault.

Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.

By class

Class	Reports
Class II	67

Checking whether it affects you

The lot or code number is what matters. Not the product name. A recall covers specific lots. Yours may not be one of them.

Check the code on your package against the report. The FDA keeps the current list at fda.gov/safety/recalls.

The reports

The text below is quoted from the FDA record word for word.

Zarxio 300 mcg/0.5 mL PFS NDC 14 days supply

D-0796-2018 · Class II · reported 2018-05-16 · Terminated

Why it was recalled: Lack of Processing Controls.
Product: Zarxio 300 mcg/0.5 mL PFS NDC 14 days supply
Where it went: MS, LA, AR, IL, FL
How much: Unknown

Gleevec 100 mg tablet NDC 00078-0401-34 30 days supply

D-0782-2018 · Class II · reported 2018-05-16 · Terminated

Why it was recalled: Lack of Processing Controls.
Product: Gleevec 100 mg tablet NDC 00078-0401-34 30 days supply
Where it went: MS, LA, AR, IL, FL
How much: Unknown

Orkambi 100 mg/125 mg Tablets #112 NDC 51167-0700-02 28 days supply.

D-0751-2018 · Class II · reported 2018-05-16 · Terminated

Why it was recalled: Lack of Processing Controls.
Product: Orkambi 100 mg/125 mg Tablets #112 NDC 51167-0700-02 28 days supply.
Where it went: MS, LA, AR, IL, FL
How much: Unknown

Copaxone 20 mg Injection PFS (30) NDC 68546-0317-30 30 days supply.

D-0766-2018 · Class II · reported 2018-05-16 · Terminated

Why it was recalled: Lack of Processing Controls.
Product: Copaxone 20 mg Injection PFS (30) NDC 68546-0317-30 30 days supply.
Where it went: MS, LA, AR, IL, FL
How much: Unknown

Tasigna Capsules 150 mg NDC 00078-0592-87 28 days supply

D-0797-2018 · Class II · reported 2018-05-16 · Terminated

Why it was recalled: Lack of Processing Controls.
Product: Tasigna Capsules 150 mg NDC 00078-0592-87 28 days supply
Where it went: MS, LA, AR, IL, FL
How much: Unknown

Humira 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 00074-433

D-0734-2018 · Class II · reported 2018-05-16 · Terminated

Why it was recalled: Lack of Processing Controls.
Product: Humira 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,
Where it went: MS, LA, AR, IL, FL
How much: Unknown

Taltz 80 mg/mL Pen 1-pk NDC 00002-1445-11 28 days supply

D-0741-2018 · Class II · reported 2018-05-16 · Terminated

Why it was recalled: Lack of Processing Controls.
Product: Taltz 80 mg/mL Pen 1-pk NDC 00002-1445-11 28 days supply
Where it went: MS, LA, AR, IL, FL
How much: Unknown

Bendeka 25 mg/mL 4 mL MDVPF NDC 63459-0348-04 28 days supply

D-0792-2018 · Class II · reported 2018-05-16 · Terminated

Why it was recalled: Lack of Processing Controls.
Product: Bendeka 25 mg/mL 4 mL MDVPF NDC 63459-0348-04 28 days supply
Where it went: MS, LA, AR, IL, FL
How much: Unknown

Otezla 30 mg tablet NDC 59572-0631-06 30 days supply;

D-0740-2018 · Class II · reported 2018-05-16 · Terminated

Why it was recalled: Lack of Processing Controls.
Product: Otezla 30 mg tablet NDC 59572-0631-06 30 days supply;
Where it went: MS, LA, AR, IL, FL
How much: Unknown

Altera Handset NDC 83490-0678-05 56 days supply

D-0743-2018 · Class II · reported 2018-05-16 · Terminated

Why it was recalled: Lack of Processing Controls.
Product: Altera Handset NDC 83490-0678-05 56 days supply
Where it went: MS, LA, AR, IL, FL
How much: Unknown

Capecitabine 500 mg Tablet NDC 00378-2512-78 28 days supply and 21 days supply

D-0791-2018 · Class II · reported 2018-05-16 · Terminated

Why it was recalled: Lack of Processing Controls.
Product: Capecitabine 500 mg Tablet NDC 00378-2512-78 28 days supply and 21 days supply
Where it went: MS, LA, AR, IL, FL
How much: Unknown

Kalydeco 150 mg tablet blister, 28 days supply, Rx Only, 39183, NDC 51167-0200-01

D-0736-2018 · Class II · reported 2018-05-16 · Terminated

Why it was recalled: Lack of Processing Controls.
Product: Kalydeco 150 mg tablet blister, 28 days supply, Rx Only, 39183, NDC 51167-0200-01
Where it went: MS, LA, AR, IL, FL
How much: Unknown

Cimzia 200 mg/mL PFS Kit #2 NDC 50474-0710-79 28 days supply.

D-0763-2018 · Class II · reported 2018-05-16 · Terminated

Why it was recalled: Lack of Processing Controls.
Product: Cimzia 200 mg/mL PFS Kit #2 NDC 50474-0710-79 28 days supply.
Where it went: MS, LA, AR, IL, FL
How much: Unknown

Sutent 50 mg capsules x28 NDC 00069-0550-38 42 days supply

D-0788-2018 · Class II · reported 2018-05-16 · Terminated

Why it was recalled: Lack of Processing Controls.
Product: Sutent 50 mg capsules x28 NDC 00069-0550-38 42 days supply
Where it went: MS, LA, AR, IL, FL
How much: Unknown

Azithromycin 250 mg tablet #18 TEV NDC 50111-0787-66 28 days supply

D-0754-2018 · Class II · reported 2018-05-16 · Terminated

Why it was recalled: Lack of Processing Controls.
Product: Azithromycin 250 mg tablet #18 TEV NDC 50111-0787-66 28 days supply
Where it went: MS, LA, AR, IL, FL
How much: Unknown

Xolair 150 mg SDV NDC 50242-0040-62 28 days

D-0758-2018 · Class II · reported 2018-05-16 · Terminated

Why it was recalled: Lack of Processing Controls.
Product: Xolair 150 mg SDV NDC 50242-0040-62 28 days
Where it went: MS, LA, AR, IL, FL
How much: Unknown

Boost VHC Oral Liquid VAN #27 NDC 43900-0182-15 27 days supply

D-0761-2018 · Class II · reported 2018-05-16 · Terminated

Why it was recalled: Lack of Processing Controls.
Product: Boost VHC Oral Liquid VAN #27 NDC 43900-0182-15 27 days supply
Where it went: MS, LA, AR, IL, FL
How much: Unknown

Bethkis 300 mg/4 mL Ampule #56 NDC 10122-0820-56 56 days supply

D-0752-2018 · Class II · reported 2018-05-16 · Terminated

Why it was recalled: Lack of Processing Controls.
Product: Bethkis 300 mg/4 mL Ampule #56 NDC 10122-0820-56 56 days supply
Where it went: MS, LA, AR, IL, FL
How much: Unknown

Dexamethasone 4 mg tablet NDC 49884-0087-01 28 days supply

D-0786-2018 · Class II · reported 2018-05-16 · Terminated

Why it was recalled: Lack of Processing Controls.
Product: Dexamethasone 4 mg tablet NDC 49884-0087-01 28 days supply
Where it went: MS, LA, AR, IL, FL
How much: Unknown

Perjeta 420 mg/14 mL SDV Vials 50242-0145-01 21 days supply

D-0795-2018 · Class II · reported 2018-05-16 · Terminated

Why it was recalled: Lack of Processing Controls.
Product: Perjeta 420 mg/14 mL SDV Vials 50242-0145-01 21 days supply
Where it went: MS, LA, AR, IL, FL
How much: Unknown

Xtandi 40 mg capsule NDC 00469-0125-99 30 days supply

D-0769-2018 · Class II · reported 2018-05-16 · Terminated

Why it was recalled: Lack of Processing Controls.
Product: Xtandi 40 mg capsule NDC 00469-0125-99 30 days supply
Where it went: MS, LA, AR, IL, FL
How much: Unknown

Sprycel 80 mg tablet NDC 00003-0855-22 30 days supply

D-0783-2018 · Class II · reported 2018-05-16 · Terminated

Why it was recalled: Lack of Processing Controls.
Product: Sprycel 80 mg tablet NDC 00003-0855-22 30 days supply
Where it went: MS, LA, AR, IL, FL
How much: Unknown

Pulmicort Respules 0.5 mg/2mL s, 30 days supply, NDC 00186-1989-04

D-0739-2018 · Class II · reported 2018-05-16 · Terminated

Why it was recalled: Lack of Processing Controls.
Product: Pulmicort Respules 0.5 mg/2mL s, 30 days supply, NDC 00186-1989-04
Where it went: MS, LA, AR, IL, FL
How much: Unknown

Pulmozyme 1 mg/mL Inh. Soln. #30 NDC 50242-0100-40 30 days supply.

D-0753-2018 · Class II · reported 2018-05-16 · Terminated

Why it was recalled: Lack of Processing Controls.
Product: Pulmozyme 1 mg/mL Inh. Soln. #30 NDC 50242-0100-40 30 days supply.
Where it went: MS, LA, AR, IL, FL
How much: Unknown

MVW Complete Softgels NDC 58204-0004-00 30 days supply; MVW Complete Chew Vitamin Grape NDC 58204-0004-15 30 d

D-0756-2018 · Class II · reported 2018-05-16 · Terminated

Why it was recalled: Lack of Processing Controls.
Product: MVW Complete Softgels NDC 58204-0004-00 30 days supply; MVW Complete Chew Vitamin Grape NDC 58204-0004-15 30 days supply.
Where it went: MS, LA, AR, IL, FL
How much: N/A

Botox 100 Units Vial NDC 00023-1145-01 90 days supply.

D-0747-2018 · Class II · reported 2018-05-16 · Terminated

Why it was recalled: Lack of Processing Controls.
Product: Botox 100 Units Vial NDC 00023-1145-01 90 days supply.
Where it went: MS, LA, AR, IL, FL
How much: Unknown

Glatiramer Acetate 40 mg/mL NDC 00378-6961-12 28 days supply

D-0778-2018 · Class II · reported 2018-05-16 · Terminated

Why it was recalled: Lack of Processing Controls.
Product: Glatiramer Acetate 40 mg/mL NDC 00378-6961-12 28 days supply
Where it went: MS, LA, AR, IL, FL
How much: Unknown

Repatha 140 mg/mL Sureclick AI 2-pk NDC 55513-0760-02 28 days supply

D-0745-2018 · Class II · reported 2018-05-16 · Terminated

Why it was recalled: Lack of Processing Controls.
Product: Repatha 140 mg/mL Sureclick AI 2-pk NDC 55513-0760-02 28 days supply
Where it went: MS, LA, AR, IL, FL
How much: Unknown

Copaxone 40 mg Injection (12) NDC 68546-0325-12 28 days supply.

D-0765-2018 · Class II · reported 2018-05-16 · Terminated

Why it was recalled: Lack of Processing Controls.
Product: Copaxone 40 mg Injection (12) NDC 68546-0325-12 28 days supply.
Where it went: MS, LA, AR, IL, FL
How much: Unknown

Sutent 37.5 mg capsules x28 NDC 00069-0830-38 28 days supply

D-0787-2018 · Class II · reported 2018-05-16 · Terminated

Why it was recalled: Lack of Processing Controls.
Product: Sutent 37.5 mg capsules x28 NDC 00069-0830-38 28 days supply
Where it went: MS, LA, AR, IL, FL
How much: Unknown

Showing the 30 most recent of 67. The rest are searchable at the FDA enforcement report database.

Read these counts with three things in mind

A firm with more recalls usually makes more products. A contract packer runs hundreds of lines. It will out-recall a company with one product whatever either does. This is not a safety ranking.

Most recalls here are voluntary. A firm found its own fault and pulled the stock. That is the system working. It lands in this database looking the same as a recall the FDA had to push for.

Terminated means the FDA considers the recall finished. It is not a verdict. It does not mean anyone was harmed.

Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.

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