thejoe THE COMPOUNDING SHOP, INC.

THE COMPOUNDING SHOP, INC.: 25 FDA recall reports

Every drug recall the FDA has published for THE COMPOUNDING SHOP, INC.. The fault, and how the agency graded it.

25Reports

0Class I

0Ongoing

2013-06-12Most 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	25

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.

Morphine Sulfate 25 mg/mL Injectable, 40 mL vial, compounded by The Compounding Shop, St. Petersburg, FL

D-568-2013 · Class II · reported 2013-06-12 · Terminated

Why it was recalled: Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Product: Morphine Sulfate 25 mg/mL Injectable, 40 mL vial, compounded by The Compounding Shop, St. Petersburg, FL
Where it went: Florida, California, Minnesota, and Maine
How much: 1 vial of 40mL

Sodium EDTA 150 mg/mL Injectable, 250 mL vial, compounded by The Compounding Shop, St. Petersburg, FL

D-557-2013 · Class II · reported 2013-06-12 · Terminated

Why it was recalled: Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Product: Sodium EDTA 150 mg/mL Injectable, 250 mL vial, compounded by The Compounding Shop, St. Petersburg, FL
Where it went: Florida, California, Minnesota, and Maine
How much: 43 vials of 250mL each

B-Complex 100 mg/mL Injectable, 50 mL vials, compounded by The Compounding Shop, St. Petersburg, FL

D-564-2013 · Class II · reported 2013-06-12 · Terminated

Why it was recalled: Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Product: B-Complex 100 mg/mL Injectable, 50 mL vials, compounded by The Compounding Shop, St. Petersburg, FL
Where it went: Florida, California, Minnesota, and Maine
How much: 56 vials of 50mL

Phosphatidyl Choline 10%, Injectable, 500 mL vial, compounded by The Compounding Shop, St. Petersburg, FL

D-565-2013 · Class II · reported 2013-06-12 · Terminated

Why it was recalled: Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Product: Phosphatidyl Choline 10%, Injectable, 500 mL vial, compounded by The Compounding Shop, St. Petersburg, FL
Where it went: Florida, California, Minnesota, and Maine
How much: 32 vials of 50mL

Baclofen 500 mcg/mL Injectable, 22 mL vial, Compounded by The Compounding Shop, St. Petersburg, FL

D-550-2013 · Class II · reported 2013-06-12 · Terminated

Why it was recalled: Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
Product: Baclofen 500 mcg/mL Injectable, 22 mL vial, Compounded by The Compounding Shop, St. Petersburg, FL
Where it went: Florida, California, Minnesota, and Maine
How much: 1 vial of 22mL

Avastin 1.25 mg/0.05 mL Injectable, 4 mL vials, Compounded by The Compounding Shop, St. Petersburg, FL

D-549-2013 · Class II · reported 2013-06-12 · Terminated

Why it was recalled: Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
Product: Avastin 1.25 mg/0.05 mL Injectable, 4 mL vials, Compounded by The Compounding Shop, St. Petersburg, FL
Where it went: Florida, California, Minnesota, and Maine
How much: 80 vials of 4mL each

Mitomycin 0.3 mg/mL Injectable, 10 mL vials, compounded by The Compounding Shop, St. Petersburg, FL

D-560-2013 · Class II · reported 2013-06-12 · Terminated

Why it was recalled: Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Product: Mitomycin 0.3 mg/mL Injectable, 10 mL vials, compounded by The Compounding Shop, St. Petersburg, FL
Where it went: Florida, California, Minnesota, and Maine
How much: 4 vials of 10mL each

Glutathione 200 mg/mL Injectable, 50 mL vials, compounded by The Compounding Shop, St. Petersburg, FL

D-558-2013 · Class II · reported 2013-06-12 · Terminated

Why it was recalled: Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Product: Glutathione 200 mg/mL Injectable, 50 mL vials, compounded by The Compounding Shop, St. Petersburg, FL
Where it went: Florida, California, Minnesota, and Maine
How much: 7 vials of 50mL each

Baclofen/Bupivacaine 2,000 mcg/20 mg/mL Injectable, 45 mL vial, Compounded by The Compounding Shop, St. Peters

D-552-2013 · Class II · reported 2013-06-12 · Terminated

Why it was recalled: Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Product: Baclofen/Bupivacaine 2,000 mcg/20 mg/mL Injectable, 45 mL vial, Compounded by The Compounding Shop, St. Petersburg, FL
Where it went: Florida, California, Minnesota, and Maine
How much: 3 vials of 45mL

Ascorbic Acid 500 mg/mL Injectable, 100 mL and 500 mL vials, compounded by The Compounding Shop, St. Petersbur

D-563-2013 · Class II · reported 2013-06-12 · Terminated

Why it was recalled: Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Product: Ascorbic Acid 500 mg/mL Injectable, 100 mL and 500 mL vials, compounded by The Compounding Shop, St. Petersburg, FL
Where it went: Florida, California, Minnesota, and Maine
How much: 78 vials of 500ml and 92 vials of 100mL

Dexpanthenol 200 mg/mL Injectable, 100 mL vial, compounded by The Compounding Shop, St. Petersburg, FL

D-554-2013 · Class II · reported 2013-06-12 · Terminated

Why it was recalled: Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Product: Dexpanthenol 200 mg/mL Injectable, 100 mL vial, compounded by The Compounding Shop, St. Petersburg, FL
Where it went: Florida, California, Minnesota, and Maine
How much: 2 vials of 100mL

Methylcobalamin 1,000 mcg/mL Injectable, 50 mL vials, compounded by The Compounding Shop, St. Petersburg, FL

D-561-2013 · Class II · reported 2013-06-12 · Terminated

Why it was recalled: Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Product: Methylcobalamin 1,000 mcg/mL Injectable, 50 mL vials, compounded by The Compounding Shop, St. Petersburg, FL
Where it went: Florida, California, Minnesota, and Maine
How much: 44 vials of 50mL each

Baclofen 1,000 mcg/mL Injectable, 20 mL and 40 mL vial, Compounded by The Compounding Shop, St. Petersburg, FL

D-551-2013 · Class II · reported 2013-06-12 · Terminated

Why it was recalled: Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
Product: Baclofen 1,000 mcg/mL Injectable, 20 mL and 40 mL vial, Compounded by The Compounding Shop, St. Petersburg, FL
Where it went: Florida, California, Minnesota, and Maine
How much: 1 vial of 20mL and 1 vial of 40mL

Praziquantel 56.8 mg, 50 mL vial, compounded by The Compounding Shop, St. Petersburg, FL

D-570-2013 · Class II · reported 2013-06-12 · Terminated

Why it was recalled: Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Product: Praziquantel 56.8 mg, 50 mL vial, compounded by The Compounding Shop, St. Petersburg, FL
Where it went: Florida, California, Minnesota, and Maine
How much: 5 vials of 50mL

Lipoic Acid 25 mg/mL Injectable, 100 mL vials, compounded by The Compounding Shop, St. Petersburg, FL

D-559-2013 · Class II · reported 2013-06-12 · Terminated

Why it was recalled: Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Product: Lipoic Acid 25 mg/mL Injectable, 100 mL vials, compounded by The Compounding Shop, St. Petersburg, FL
Where it went: Florida, California, Minnesota, and Maine
How much: 55 vials of 100mL

Betamethasone 6 mg/mL Injectable, 5 mL vial, compounded by The Compounding Shop, St. Petersburg, FL

D-553-2013 · Class II · reported 2013-06-12 · Terminated

Why it was recalled: Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Product: Betamethasone 6 mg/mL Injectable, 5 mL vial, compounded by The Compounding Shop, St. Petersburg, FL
Where it went: Florida, California, Minnesota, and Maine
How much: 20 vials of 5mL

Dexamethasone 10 mg/mL Injectable, 2 mL vial, compounded by The Compounding Shop, St. Petersburg, FL

D-555-2013 · Class II · reported 2013-06-12 · Terminated

Why it was recalled: Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Product: Dexamethasone 10 mg/mL Injectable, 2 mL vial, compounded by The Compounding Shop, St. Petersburg, FL
Where it went: Florida, California, Minnesota, and Maine
How much: 41 vials of 2mL

Procaine 1% Injectable, 100 mL and 250 mL vials, compounded by The Compounding Shop, St. Petersburg, FL

D-562-2013 · Class II · reported 2013-06-12 · Terminated

Why it was recalled: Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Product: Procaine 1% Injectable, 100 mL and 250 mL vials, compounded by The Compounding Shop, St. Petersburg, FL
Where it went: Florida, California, Minnesota, and Maine
How much: 2 vials of 250mL and 26 vials of 100mL

Testosterone Cypionate 200 mg/mL Injectable, 10 mL vials, compounded by The Compounding Shop, St. Petersburg,

D-567-2013 · Class II · reported 2013-06-12 · Terminated

Why it was recalled: Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Product: Testosterone Cypionate 200 mg/mL Injectable, 10 mL vials, compounded by The Compounding Shop, St. Petersburg, FL
Where it went: Florida, California, Minnesota, and Maine
How much: 1 vial of 6mL, 19 vials of 10mL each and 1 vial of 40mL

MIC (Methionine, Inositol, and Choline) + B12 25/50/50mg/1000mcg/mL Injectable, 30 mL vials, compounded by The

D-566-2013 · Class II · reported 2013-06-12 · Terminated

Why it was recalled: Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Product: MIC (Methionine, Inositol, and Choline) + B12 25/50/50mg/1000mcg/mL Injectable, 30 mL vials, compounded by The Compounding Shop, St. Petersburg, FL
Where it went: Florida, California, Minnesota, and Maine
How much: 14 vials of 30mL each

Hydroxyprogesterone 250 mg/mL Injectable, 4 mL, 6 mL,8 mL and 10 mL vials, compounded by The Compounding Shop,

D-556-2013 · Class II · reported 2013-06-12 · Terminated

Why it was recalled: Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Product: Hydroxyprogesterone 250 mg/mL Injectable, 4 mL, 6 mL,8 mL and 10 mL vials, compounded by The Compounding Shop, St. Petersburg, FL
Where it went: Florida, California, Minnesota, and Maine
How much: 12 vials of 4mL, 1 vial of 6 mL, 1 vial of 8 mLand 3 vials of 10mL

Carnosine 5% Opth drop, 40 mL vial, compounded by The Compounding Shop, St. Petersburg, FL

D-569-2013 · Class II · reported 2013-06-12 · Terminated

Why it was recalled: Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Product: Carnosine 5% Opth drop, 40 mL vial, compounded by The Compounding Shop, St. Petersburg, FL
Where it went: Florida, California, Minnesota, and Maine
How much: 1 vial of 40ml

Methotrexate 25mg/mL Injectable, 10 mL vials, Compounded by The Compounding Shop, St. Petersburg, FL

D-548-2013 · Class II · reported 2013-06-12 · Terminated

Why it was recalled: Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
Product: Methotrexate 25mg/mL Injectable, 10 mL vials, Compounded by The Compounding Shop, St. Petersburg, FL
Where it went: Florida, California, Minnesota, and Maine
How much: 19 vials of 10ml

MIC (Methionine, Inositol, and Choline) Injectable, 30 mL vials, compounded by The Compounding Shop, St. Peter

D-571-2013 · Class II · reported 2013-06-12 · Terminated

Why it was recalled: Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Product: MIC (Methionine, Inositol, and Choline) Injectable, 30 mL vials, compounded by The Compounding Shop, St. Petersburg, FL
Where it went: Florida, California, Minnesota, and Maine
How much: 10 vials of 30 mL each

Tri-Mix Injections in 5 mL and 10 mL vials (Alprostadil, Phentolamine and Papaverine), compounded by The Compo

D-572-2013 · Class II · reported 2013-06-12 · Terminated

Why it was recalled: Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Product: Tri-Mix Injections in 5 mL and 10 mL vials (Alprostadil, Phentolamine and Papaverine), compounded by The Compounding Shop, St. Petersburg, FL
Where it went: Florida, California, Minnesota, and Maine
How much: 4 vials of 5mL and 22 vials of 10mL

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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