thejoe The Compounding Pharmacy of America

The Compounding Pharmacy of America: 383 FDA recall reports

Every drug recall the FDA has published for The Compounding Pharmacy of America. The fault, and how the agency graded it.

383Reports

1Class I

0Ongoing

2018-02-21Most recent

1 Class I on this page

Class I means the FDA judged there was a reasonable probability of serious harm or death. Check the lot numbers against anything you hold.

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	382
Class I	1

By year reported

Year	Reports
2015	382
2018	1

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.

Class I

HCG 5,000 IU/mL + Methylcobalamin 500 mcg/mL Injection 5 mL, Multi-Dose Vial, Sterile, Rx Only, Compounded by

D-0600-2018 · Class I · reported 2018-02-21 · Terminated

Why it was recalled: Non-Sterility
Product: HCG 5,000 IU/mL + Methylcobalamin 500 mcg/mL Injection 5 mL, Multi-Dose Vial, Sterile, Rx Only, Compounded by The Compounding Pharmacy of America, 6216 Highland Place Way, Ste. 101A Knoxville, TN 37919 Ph (855) 277-2488 Fax (888) 689-9892
Where it went: TN, SC
How much: 5 vials

HCG 1,100 IU/ml Injection, Multi-Dose Vial, Sterile, Refrigerate The Compounding Pharmacy of America, Knoxvill

D-1519-2015 · Class II · reported 2015-09-23 · Terminated

Why it was recalled: Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Product: HCG 1,100 IU/ml Injection, Multi-Dose Vial, Sterile, Refrigerate The Compounding Pharmacy of America, Knoxville, TN
Where it went: Nationwide
How much: 1558 ml total

Testosterone 20 mg, Sterile Pellet, The Compounding Pharmacy of America, Knoxville, TN

D-1744-2015 · Class II · reported 2015-09-23 · Terminated

Why it was recalled: Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Product: Testosterone 20 mg, Sterile Pellet, The Compounding Pharmacy of America, Knoxville, TN
Where it went: Nationwide
How much: 24 pellets

HCG 1,250 IU/ml Injection, Multi-Dose Vial, Sterile, Refrigerate The Compounding Pharmacy of America, Knoxvill

D-1523-2015 · Class II · reported 2015-09-23 · Terminated

Why it was recalled: Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Product: HCG 1,250 IU/ml Injection, Multi-Dose Vial, Sterile, Refrigerate The Compounding Pharmacy of America, Knoxville, TN
Where it went: Nationwide
How much: 55 ml total

Hydromorphone 30 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

D-1549-2015 · Class II · reported 2015-09-23 · Terminated

Why it was recalled: Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Product: Hydromorphone 30 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN
Where it went: Nationwide
How much: 44 ml total

Morphine 60 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

D-1612-2015 · Class II · reported 2015-09-23 · Terminated

Why it was recalled: Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Product: Morphine 60 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN
Where it went: Nationwide
How much: 43 ml total volume

Hyaluronic Acid Sodium 28 mg/ml + Lidocaine HCl 3 mg/ml Injection, ml Syringe, Sterile, Room Temperature, The

D-1534-2015 · Class II · reported 2015-09-23 · Terminated

Why it was recalled: Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Product: Hyaluronic Acid Sodium 28 mg/ml + Lidocaine HCl 3 mg/ml Injection, ml Syringe, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN
Where it went: Nationwide
How much: 20 ml total

Hydromorphone 50 mg/ml + Fentanyl 3,000 mcg/ml + Bupivacaine 20 mg/ml Intrathecal Solution, Sterile-Preservati

D-1675-2015 · Class II · reported 2015-09-23 · Terminated

Why it was recalled: Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Product: Hydromorphone 50 mg/ml + Fentanyl 3,000 mcg/ml + Bupivacaine 20 mg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN
Where it went: Nationwide
How much: 23 ml

Hydromorphone 80 mg/ml + Bupivacaine 10 mg/ml + Clonidine 1,000 mcg/ml, Baclofen 500 mcg/ml Intrathecal Soluti

D-1682-2015 · Class II · reported 2015-09-23 · Terminated

Why it was recalled: Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Product: Hydromorphone 80 mg/ml + Bupivacaine 10 mg/ml + Clonidine 1,000 mcg/ml, Baclofen 500 mcg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN
Where it went: Nationwide
How much: 22 ml

Fentanyl 2,000 mcg/ml + Bupivacaine 20 mg/ml Intrathecal Solution, Sterile - Preservative Free, The Compoundin

D-1492-2015 · Class II · reported 2015-09-23 · Terminated

Why it was recalled: Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Product: Fentanyl 2,000 mcg/ml + Bupivacaine 20 mg/ml Intrathecal Solution, Sterile - Preservative Free, The Compounding Pharmacy of America, Knoxville, TN
Where it went: Nationwide
How much: 43 ml total volume

Morphine 25 mg/ml + Bupivacaine 30 mg/ml + Clonidine 200 mcg/ml Solution, Sterile, Preservative Free, The Comp

D-1702-2015 · Class II · reported 2015-09-23 · Terminated

Why it was recalled: Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Product: Morphine 25 mg/ml + Bupivacaine 30 mg/ml + Clonidine 200 mcg/ml Solution, Sterile, Preservative Free, The Compounding Pharmacy of America, Knoxville, TN
Where it went: Nationwide
How much: 43 ml

Testosterone 12.5 mg, Sterile Pellet, The Compounding Pharmacy of America, Knoxville, TN

D-1743-2015 · Class II · reported 2015-09-23 · Terminated

Why it was recalled: Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Product: Testosterone 12.5 mg, Sterile Pellet, The Compounding Pharmacy of America, Knoxville, TN
Where it went: Nationwide
How much: 144 pellets

Hydromorphone 80 mg/ml + Fentanyl 15,000 mcg/ml + Bupivacaine 30 mg/ml + Baclofen 750 mcg/ml Intrathecal Solut

D-1732-2015 · Class II · reported 2015-09-23 · Terminated

Why it was recalled: Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Product: Hydromorphone 80 mg/ml + Fentanyl 15,000 mcg/ml + Bupivacaine 30 mg/ml + Baclofen 750 mcg/ml Intrathecal Solution, The Compounding Pharmacy of America, Knoxville, TN
Where it went: Nationwide
How much: 22 ml

Tri-Mix AT-6 (60 mg/4 mg/0.3 mg) Injectable, The Compounding Pharmacy of America, Knoxville, TN

D-1789-2015 · Class II · reported 2015-09-23 · Terminated

Why it was recalled: Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Product: Tri-Mix AT-6 (60 mg/4 mg/0.3 mg) Injectable, The Compounding Pharmacy of America, Knoxville, TN
Where it went: Nationwide
How much: 70 ml

B-Complex 100 mg/ml Injection, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN

D-1726-2015 · Class II · reported 2015-09-23 · Terminated

Why it was recalled: Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Product: B-Complex 100 mg/ml Injection, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN
Where it went: Nationwide
How much: 33 ML

PGE 2 (Alprostadil) 100 mcg/ml, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN

D-1740-2015 · Class II · reported 2015-09-23 · Terminated

Why it was recalled: Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Product: PGE 2 (Alprostadil) 100 mcg/ml, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN
Where it went: Nationwide
How much: 25 ml

Morphine 25 mg/ml + Bupivacaine 20 mg/ml + Clonidine 2,000 mcg/ml Solution, Sterile, Preservative Free, The Co

D-1701-2015 · Class II · reported 2015-09-23 · Terminated

Why it was recalled: Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Product: Morphine 25 mg/ml + Bupivacaine 20 mg/ml + Clonidine 2,000 mcg/ml Solution, Sterile, Preservative Free, The Compounding Pharmacy of America, Knoxville, TN
Where it went: Nationwide
How much: 44 ml

Morphine 12.5 mg/ml Solution, Sterile-Preservative Free,The Compounding Pharmacy of America, Knoxville, TN

D-1586-2015 · Class II · reported 2015-09-23 · Terminated

Why it was recalled: Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Product: Morphine 12.5 mg/ml Solution, Sterile-Preservative Free,The Compounding Pharmacy of America, Knoxville, TN
Where it went: Nationwide
How much: 151 ml total volume

Quad-Mix 4 Injectable, Multi-Dose Vial, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville,

D-1718-2015 · Class II · reported 2015-09-23 · Terminated

Why it was recalled: Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Product: Quad-Mix 4 Injectable, Multi-Dose Vial, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN
Where it went: Nationwide
How much: 45 ml

Phosphatidylcholine 0.1% Sodium Deoxycholate 0.089% Injection, Vial, Sterile, Refrigerate, The Compounding Pha

D-1623-2015 · Class II · reported 2015-09-23 · Terminated

Why it was recalled: Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Product: Phosphatidylcholine 0.1% Sodium Deoxycholate 0.089% Injection, Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN
Where it went: Nationwide
How much: 100 ml total volume

L-Arginine 100 mg/ml Injectable, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, K

D-1561-2015 · Class II · reported 2015-09-23 · Terminated

Why it was recalled: Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Product: L-Arginine 100 mg/ml Injectable, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN
Where it went: Nationwide
How much: 63 ml total

Hydromorphone 20 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

D-1547-2015 · Class II · reported 2015-09-23 · Terminated

Why it was recalled: Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Product: Hydromorphone 20 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN
Where it went: Nationwide
How much: 130 ml total

Morphine 50 mg/ml + Clonidine 200 mcg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of Amer

D-1610-2015 · Class II · reported 2015-09-23 · Terminated

Why it was recalled: Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Product: Morphine 50 mg/ml + Clonidine 200 mcg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN
Where it went: Nationwide
How much: 129 ml total volume

Mitomycin 40 mg/50 ml Sodium Chloride 0.9% Injection, Single Dose Syringe, The Compounding Pharmacy of America

D-1584-2015 · Class II · reported 2015-09-23 · Terminated

Why it was recalled: Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Product: Mitomycin 40 mg/50 ml Sodium Chloride 0.9% Injection, Single Dose Syringe, The Compounding Pharmacy of America, Knoxville, TN
Where it went: Nationwide
How much: 315 ml total volume

Acetylcysteine 100 mg/ml Injectable, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of Americ

D-1435-2015 · Class II · reported 2015-09-23 · Terminated

Why it was recalled: Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Product: Acetylcysteine 100 mg/ml Injectable, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN
Where it went: Nationwide
How much: 99 mL total

HCG 1,000 IU/ml Injection, Multi-Dose Vial, Sterile, Refrigerate, 23 DAY KIT, The Compounding Pharmacy of Amer

D-1512-2015 · Class II · reported 2015-09-23 · Terminated

Why it was recalled: Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Product: HCG 1,000 IU/ml Injection, Multi-Dose Vial, Sterile, Refrigerate, 23 DAY KIT, The Compounding Pharmacy of America, Knoxville, TN
Where it went: Nationwide
How much: 4 ml

Tri-Mix (17.7 mg/0.59 mg/6 mcg) Injectable, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxvi

D-1764-2015 · Class II · reported 2015-09-23 · Terminated

Why it was recalled: Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Product: Tri-Mix (17.7 mg/0.59 mg/6 mcg) Injectable, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN
Where it went: Nationwide
How much: 307 ml total

Baclofen 2,500 mcg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Kn

D-1725-2015 · Class II · reported 2015-09-23 · Terminated

Why it was recalled: Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Product: Baclofen 2,500 mcg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN
Where it went: Nationwide
How much: 100 ML

Tri-Mix (6.9/0.575/39.375) Injectable, The Compounding Pharmacy of America, Knoxville, TN

D-1787-2015 · Class II · reported 2015-09-23 · Terminated

Why it was recalled: Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Product: Tri-Mix (6.9/0.575/39.375) Injectable, The Compounding Pharmacy of America, Knoxville, TN
Where it went: Nationwide
How much: 6 ml

Tri-Mix Super Injectable, Multi-Dose Vial, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxvill

D-1720-2015 · Class II · reported 2015-09-23 · Terminated

Why it was recalled: Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Product: Tri-Mix Super Injectable, Multi-Dose Vial, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN
Where it went: Nationwide

Showing the 30 most recent of 383. 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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