Axium Healthcare Pharmacy dba Balanced

Axium Healthcare Pharmacy dba Balanced Solutions Compounding: 26 FDA recall reports

Every drug recall the FDA has published for Axium Healthcare Pharmacy dba Balanced Solutions Compounding. The fault, and how the agency graded it.

26Reports
0Class I
0Ongoing
2013-05-01Most 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.

ClassWhat the FDA is saying
Class IThere is a reasonable probability that using this will cause serious harm or death.
Class IIIt may cause temporary or reversible harm. Serious harm is unlikely.
Class IIIIt 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

ClassReports
Class II26
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.

Trimix Customs Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy,

D-282-2013  ·  Class II  ·  reported 2013-05-01  ·  Terminated

Why it was recalled
Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.
Product
Trimix Customs Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746
Where it went
CO, GA, MI, and Puerto Rico
How much
61 vials (5 mL and 10 mL vials)

Cyclosporin in Corn Oil Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Ph

D-295-2013  ·  Class II  ·  reported 2013-05-01  ·  Terminated

Why it was recalled
Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.
Product
Cyclosporin in Corn Oil Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746
Where it went
CO, GA, MI, and Puerto Rico
How much
1 vial (15 mL)

Triamcinolone Acetonide Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare P

D-291-2013  ·  Class II  ·  reported 2013-05-01  ·  Terminated

Why it was recalled
Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.
Product
Triamcinolone Acetonide Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746
Where it went
CO, GA, MI, and Puerto Rico
How much
18 viasl (10 mL each)

TriMix Standartd (PGE Stock Sol'n) Injectable Balanced Solutions, Compounding Pharmacy a division of Axium H

D-270-2013  ·  Class II  ·  reported 2013-05-01  ·  Terminated

Why it was recalled
Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.
Product
TriMix Standartd (PGE Stock Sol'n) Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746
Where it went
CO, GA, MI, and Puerto Rico
How much
380 vials (5 mL and 10 mL vials)

Bacteriostatic Water for Injection 0.9% Injectable Balanced Solutions, Compounding Pharmacy a division of Axi

D-289-2013  ·  Class II  ·  reported 2013-05-01  ·  Terminated

Why it was recalled
Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.
Product
Bacteriostatic Water for Injection 0.9% Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746
Where it went
CO, GA, MI, and Puerto Rico

Quadmix Custom Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, I

D-285-2013  ·  Class II  ·  reported 2013-05-01  ·  Terminated

Why it was recalled
Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.
Product
Quadmix Custom Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746
Where it went
CO, GA, MI, and Puerto Rico
How much
3 vials (10 mL vials)

Triamcinolone Diacetate Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Ph

D-290-2013  ·  Class II  ·  reported 2013-05-01  ·  Terminated

Why it was recalled
Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.
Product
Triamcinolone Diacetate Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746
Where it went
CO, GA, MI, and Puerto Rico
How much
172 vials (5 mL vials each)

Betamethasone Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, In

D-273-2013  ·  Class II  ·  reported 2013-05-01  ·  Terminated

Why it was recalled
Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.
Product
Betamethasone Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746
Where it went
CO, GA, MI, and Puerto Rico
How much
401 vials (10 mL vials each)

HCG Lyophylized Powder 10,000 unit for Injectable Balanced Solutions, Compounding Pharmacy a division of Axiu

D-292-2013  ·  Class II  ·  reported 2013-05-01  ·  Terminated

Why it was recalled
Lack of Sterility Assurance
Product
HCG Lyophylized Powder 10,000 unit for Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746
Where it went
CO, GA, MI, and Puerto Rico
How much
1 vial (10 mL)

Triamcinolone Hexacetonide Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare

D-274-2013  ·  Class II  ·  reported 2013-05-01  ·  Terminated

Why it was recalled
Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.
Product
Triamcinolone Hexacetonide Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746
Where it went
CO, GA, MI, and Puerto Rico
How much
28 vials (10 mL each)

Sodium Tetradecyl Sulfate for Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthc

D-293-2013  ·  Class II  ·  reported 2013-05-01  ·  Terminated

Why it was recalled
Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.
Product
Sodium Tetradecyl Sulfate for Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746
Where it went
CO, GA, MI, and Puerto Rico
How much
5 vials (30 mL each)

Methylcobalamin and Folic Acid Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Health

D-276-2013  ·  Class II  ·  reported 2013-05-01  ·  Terminated

Why it was recalled
Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.
Product
Methylcobalamin and Folic Acid Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746
Where it went
CO, GA, MI, and Puerto Rico
How much
29 vials (9 mL and 30 mL)

QuadMix Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., La

D-287-2013  ·  Class II  ·  reported 2013-05-01  ·  Terminated

Why it was recalled
Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.
Product
QuadMix Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746
Where it went
CO, GA, MI, and Puerto Rico
How much
3 vials (10 mL each)

Mono-mix (Prostaglandin) Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare

D-281-2013  ·  Class II  ·  reported 2013-05-01  ·  Terminated

Why it was recalled
Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.
Product
Mono-mix (Prostaglandin) Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746
Where it went
CO, GA, MI, and Puerto Rico
How much
15 vials (10 mL each)

Methylprednisolone Acetate injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare

D-271-2013  ·  Class II  ·  reported 2013-05-01  ·  Terminated

Why it was recalled
Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.
Product
Methylprednisolone Acetate injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746
Where it went
CO, GA, MI, and Puerto Rico
How much
326 vials (10 mL each)

Cyanocobalamin (CMP) Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharm

D-275-2013  ·  Class II  ·  reported 2013-05-01  ·  Terminated

Why it was recalled
Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.
Product
Cyanocobalamin (CMP) Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746
Where it went
CO, GA, MI, and Puerto Rico
How much
15 vials ((30 mL each)

Phosphatidylcholine Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharma

D-279-2013  ·  Class II  ·  reported 2013-05-01  ·  Terminated

Why it was recalled
Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.
Product
Phosphatidylcholine Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746
Where it went
CO, GA, MI, and Puerto Rico
How much
5 vials (3 mL each)

Cyclosporin (Grapeseed Oil) Ophthalmic Balanced Solutions, Compounding Pharmacy a division of Axium Healthcar

D-278-2013  ·  Class II  ·  reported 2013-05-01  ·  Terminated

Why it was recalled
Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.
Product
Cyclosporin (Grapeseed Oil) Ophthalmic Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746
Where it went
CO, GA, MI, and Puerto Rico
How much
12 vials (15 mL each)

DMSO 50% Sterile Bladder Irrigation Solution Injectable Balanced Solutions, Compounding Pharmacy a division o

D-288-2013  ·  Class II  ·  reported 2013-05-01  ·  Terminated

Why it was recalled
Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.
Product
DMSO 50% Sterile Bladder Irrigation Solution Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746
Where it went
CO, GA, MI, and Puerto Rico
How much
2 50 mL vials

BiMix Plus Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc.,

D-284-2013  ·  Class II  ·  reported 2013-05-01  ·  Terminated

Why it was recalled
Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.
Product
BiMix Plus Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746
Where it went
CO, GA, MI, and Puerto Rico
How much
6 vials (5 mL and 10 mL each)

BiMix Customs Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, In

D-294-2013  ·  Class II  ·  reported 2013-05-01  ·  Terminated

Why it was recalled
Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.
Product
BiMix Customs Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746
Where it went
CO, GA, MI, and Puerto Rico
How much
1 vial (10 mL)

17 Alpha Hydroxyprogesterone Caproate Injectable Balanced Solutions, Compounding Pharmacy a division of Axium

D-286-2013  ·  Class II  ·  reported 2013-05-01  ·  Terminated

Why it was recalled
Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.
Product
17 Alpha Hydroxyprogesterone Caproate Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746
Where it went
CO, GA, MI, and Puerto Rico
How much
4 vials (5 mL each)

Sodium Tetradecyl Sulfate Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare

D-272-2013  ·  Class II  ·  reported 2013-05-01  ·  Terminated

Why it was recalled
Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.
Product
Sodium Tetradecyl Sulfate Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746
Where it went
CO, GA, MI, and Puerto Rico
How much
286 vials (30 mL vials each)

BiMix Standard Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, I

D-283-2013  ·  Class II  ·  reported 2013-05-01  ·  Terminated

Why it was recalled
Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.
Product
BiMix Standard Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746
Where it went
CO, GA, MI, and Puerto Rico

Comprehensive injection #4 - SS varied injectable Injectable Balanced Solutions, Compounding Pharmacy a divis

D-280-2013  ·  Class II  ·  reported 2013-05-01  ·  Terminated

Why it was recalled
Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.
Product
Comprehensive injection #4 - SS varied injectable Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746
Where it went
CO, GA, MI, and Puerto Rico
How much
10 vials (30 mL each)

Progesterone in Olive Oil Injectable Balanced Solutions, Compounding Pharmacy a division ofAxium Healthcare P

D-277-2013  ·  Class II  ·  reported 2013-05-01  ·  Terminated

Why it was recalled
Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.
Product
Progesterone in Olive Oil Injectable Balanced Solutions, Compounding Pharmacy a division ofAxium Healthcare Pharmacy, Inc., Lake Mary, FL 32746
Where it went
CO, GA, MI, and Puerto Rico
How much
11 vials (10 mL each)
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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