Fusion IV Pharmaceuticals, Inc. dba Ax

Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical: 64 FDA recall reports

Every drug recall the FDA has published for Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical. The fault, and how the agency graded it.

64Reports
0Class I
0Ongoing
2020-03-11Most 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 II63
Class III1

By year reported

YearReports
20171
202063
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.

Polyoxyl Lauryl Ether (Polidocanol) Injection, LAURETH-9 (POLIDOCANOL) 5% INJECTABLE, For IV Use, 30 mL Multi-

D-0960-2020  ·  Class II  ·  reported 2020-03-11  ·  Terminated

Why it was recalled
Lack of Assurance of Sterility
Product
Polyoxyl Lauryl Ether (Polidocanol) Injection, LAURETH-9 (POLIDOCANOL) 5% INJECTABLE, For IV Use, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-060-3
Where it went
U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic
How much
N/A

Alprostadil/Papaverine Hydrochloride/Phentolamine Mesylate Injection 20MCG/30MG/1MG/ML Injectable, For Intrac

D-0937-2020  ·  Class II  ·  reported 2020-03-11  ·  Terminated

Why it was recalled
Lack of Assurance of Sterility
Product
Alprostadil/Papaverine Hydrochloride/Phentolamine Mesylate Injection 20MCG/30MG/1MG/ML Injectable, For Intracavernosal Use, Freeze, 2.5 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0545-2
Where it went
U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic
How much
N/A

BETAMETHASONE ACETATE/BETAMETHASONE (PF) Injectable Suspension, Betamethasone Acetate/Betamethasone (PF) CMC [

D-0943-2020  ·  Class II  ·  reported 2020-03-11  ·  Terminated

Why it was recalled
Lack of Assurance of Sterility
Product
BETAMETHASONE ACETATE/BETAMETHASONE (PF) Injectable Suspension, Betamethasone Acetate/Betamethasone (PF) CMC [10ML] 7MG/ML INJ SUSP, For IM, IA Use, Shake Well, 10 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0621-1
Where it went
U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic
How much
N/A

Methylprednisolone Acetate Injectable Suspension, METHYLPREDNISOLONE ACETATE [10ML] CMC 100 MG/ML INJ SUSP, Fo

D-0971-2020  ·  Class II  ·  reported 2020-03-11  ·  Terminated

Why it was recalled
Lack of Assurance of Sterility
Product
Methylprednisolone Acetate Injectable Suspension, METHYLPREDNISOLONE ACETATE [10ML] CMC 100 MG/ML INJ SUSP, For IM, IA Use, Shake Well, 10 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0619-1
Where it went
U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic
How much
N/A

Selenium Injection, SELENIUM 200MCG/ML INJECTABLE, For IV Use, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceu

D-0981-2020  ·  Class II  ·  reported 2020-03-11  ·  Terminated

Why it was recalled
Lack of Assurance of Sterility
Product
Selenium Injection, SELENIUM 200MCG/ML INJECTABLE, For IV Use, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0227-3
Where it went
U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic
How much
N/A

AscorbiX (Buffered C) Injection, Ascorbix (50ML) 500MG/ML Injectable, For IV, IM, SC Use, Refrigerate, 30 mL M

D-0940-2020  ·  Class II  ·  reported 2020-03-11  ·  Terminated

Why it was recalled
Lack of Assurance of Sterility
Product
AscorbiX (Buffered C) Injection, Ascorbix (50ML) 500MG/ML Injectable, For IV, IM, SC Use, Refrigerate, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0226-5
Where it went
U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic
How much
N/A

Glutathione Injection,GLUTATHIONE 200MG/ML INJECTABLE For IV, IM Use, Refrigerate, 30 mL Multi-dose Vial, Rx

D-0953-2020  ·  Class II  ·  reported 2020-03-11  ·  Terminated

Why it was recalled
Lack of Assurance of Sterility
Product
Glutathione Injection,GLUTATHIONE 200MG/ML INJECTABLE For IV, IM Use, Refrigerate, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-1231-3
Where it went
U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic
How much
N/A

Alprostadil (prostaglandin E1) 80 MCG/ML Injectable, For Intracavernosal Use, Freeze, 2.5 mL Multi-dose Vial,

D-0936-2020  ·  Class II  ·  reported 2020-03-11  ·  Terminated

Why it was recalled
Lack of Assurance of Sterility
Product
Alprostadil (prostaglandin E1) 80 MCG/ML Injectable, For Intracavernosal Use, Freeze, 2.5 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0543-2
Where it went
U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic
How much
N/A

Glycine Injection,GLYCINE USP 50MG/ML INJECTABLE, For IV, IM Use,30 mL Multi-dose Vial, Rx only, Axia Pharma

D-0955-2020  ·  Class II  ·  reported 2020-03-11  ·  Terminated

Why it was recalled
Lack of Assurance of Sterility
Product
Glycine Injection,GLYCINE USP 50MG/ML INJECTABLE, For IV, IM Use,30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0344-3
Where it went
U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic
How much
N/A

Methionine/Inositol/Choline Injection, METHIONINE/INOSITOL/CHOLINE 25MG/50MG/50MG/ML INJECTABLE, For IM Use, 3

D-0965-2020  ·  Class II  ·  reported 2020-03-11  ·  Terminated

Why it was recalled
Lack of Assurance of Sterility
Product
Methionine/Inositol/Choline Injection, METHIONINE/INOSITOL/CHOLINE 25MG/50MG/50MG/ML INJECTABLE, For IM Use, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0215-3
Where it went
U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic
How much
N/A

Triamcinolone Diacetate Injectable Suspension, TRIAMCINOLONE DIACETATE [10ML] CMC 80 MG/ML INJ SUSP, For IM, I

D-0991-2020  ·  Class II  ·  reported 2020-03-11  ·  Terminated

Why it was recalled
Lack of Assurance of Sterility
Product
Triamcinolone Diacetate Injectable Suspension, TRIAMCINOLONE DIACETATE [10ML] CMC 80 MG/ML INJ SUSP, For IM, IA, IT Use, 10 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0634-1
Where it went
U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic
How much
N/A

MIC-PLUS Injection, Vitamin Complex, MIC-COMBO* 25MG/50MG/50MG/1MG/20MG/5MG/ML INJECTABLE, For IM Use, Refrige

D-0975-2020  ·  Class II  ·  reported 2020-03-11  ·  Terminated

Why it was recalled
Lack of Assurance of Sterility
Product
MIC-PLUS Injection, Vitamin Complex, MIC-COMBO* 25MG/50MG/50MG/1MG/20MG/5MG/ML INJECTABLE, For IM Use, Refrigerate, Protect From Light, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0231-3
Where it went
U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic
How much
N/A

Alprostadil/Papaverine Hydrochloride/Phentolamine Mesylate/Atropine Sulfate Injection, 60 mcg/30 mg/2 mg/0.15m

D-0934-2020  ·  Class II  ·  reported 2020-03-11  ·  Terminated

Why it was recalled
Lack of Assurance of Sterility
Product
Alprostadil/Papaverine Hydrochloride/Phentolamine Mesylate/Atropine Sulfate Injection, 60 mcg/30 mg/2 mg/0.15mg/ml, For Intracavernosal Use, Freeze, 2.5 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0550-2
Where it went
U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic
How much
N/A

Lidocaine HCL (PF) Injection, LIDOCAINE HCL 4% (PF) 40 MG/ML INJECTABLE, For ocular injection, Preservative f

D-0962-2020  ·  Class II  ·  reported 2020-03-11  ·  Terminated

Why it was recalled
Lack of Assurance of Sterility
Product
Lidocaine HCL (PF) Injection, LIDOCAINE HCL 4% (PF) 40 MG/ML INJECTABLE, For ocular injection, Preservative free, discard unused portion, protect from light, 5 mL Single-use Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-1011-5
Where it went
U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic
How much
N/A

Triamcinolone Diacetate Injectable Suspension, TRIAMCINOLONE DIACETATE (PF) [2ML] CMC 40 MG/ML INJ SUSP, For I

D-0990-2020  ·  Class II  ·  reported 2020-03-11  ·  Terminated

Why it was recalled
Lack of Assurance of Sterility
Product
Triamcinolone Diacetate Injectable Suspension, TRIAMCINOLONE DIACETATE (PF) [2ML] CMC 40 MG/ML INJ SUSP, For IM, IA, IT Use, 2 mL Single Use Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0628-2
Where it went
U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic
How much
N/A

Testosterone Cypionate/Progesterone Injection, TESTOSTERONE CYP/PROGESTERONE [2ML] 200MG/2.5MG/ML INJECTABLE,

D-0985-2020  ·  Class II  ·  reported 2020-03-11  ·  Terminated

Why it was recalled
Lack of Assurance of Sterility
Product
Testosterone Cypionate/Progesterone Injection, TESTOSTERONE CYP/PROGESTERONE [2ML] 200MG/2.5MG/ML INJECTABLE, For IM Use, 2 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0531-2
Where it went
U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic
How much
N/A

Alprostadil (prostaglandin E1)150 MCG/ML Injectable, For Intracavernosal Use, Freeze, 2.5 mL Multi-dose Vial,

D-0935-2020  ·  Class II  ·  reported 2020-03-11  ·  Terminated

Why it was recalled
Lack of Assurance of Sterility
Product
Alprostadil (prostaglandin E1)150 MCG/ML Injectable, For Intracavernosal Use, Freeze, 2.5 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0538-2
Where it went
U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic
How much
N/A

Hydroxyprogesterone Caproate Injection, HYDROXYPROGESTERONE CAPROATE [4ML] 250 MG/ML INJECTABLE, For IV, IM Us

D-0958-2020  ·  Class II  ·  reported 2020-03-11  ·  Terminated

Why it was recalled
Lack of Assurance of Sterility
Product
Hydroxyprogesterone Caproate Injection, HYDROXYPROGESTERONE CAPROATE [4ML] 250 MG/ML INJECTABLE, For IV, IM Use, Refrigerate, 4 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0532-5
Where it went
U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic
How much
N/A

Human Chorionic Gonadotropin (hCG) Injection, HCG [10ML] 1000 IU/ML INJECTABLE, For IM, SC Use, Refrigerate,10

D-0956-2020  ·  Class II  ·  reported 2020-03-11  ·  Terminated

Why it was recalled
Lack of Assurance of Sterility
Product
Human Chorionic Gonadotropin (hCG) Injection, HCG [10ML] 1000 IU/ML INJECTABLE, For IM, SC Use, Refrigerate,10 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0533-1
Where it went
U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic
How much
N/A

Alprostadil/Papaverine Hydrochloride/Phentolamine Mesylate Injection 40MCG/30MG/2MG/ML Injectable, For Intrac

D-0938-2020  ·  Class II  ·  reported 2020-03-11  ·  Terminated

Why it was recalled
Lack of Assurance of Sterility
Product
Alprostadil/Papaverine Hydrochloride/Phentolamine Mesylate Injection 40MCG/30MG/2MG/ML Injectable, For Intracavernosal Use, Freeze, 2.5 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0546-2
Where it went
U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic
How much
N/A

Biotin (Vitamin H) Injectable Suspension, BIOTIN 10 MG/ML INJ SUSP, For IM Use, Refrigerate, Shake Well, 30 mL

D-0945-2020  ·  Class II  ·  reported 2020-03-11  ·  Terminated

Why it was recalled
Lack of Assurance of Sterility
Product
Biotin (Vitamin H) Injectable Suspension, BIOTIN 10 MG/ML INJ SUSP, For IM Use, Refrigerate, Shake Well, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0220-3
Where it went
U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic
How much
N/A

Methylcobalamin Injection, METHYLCOBALAMIN [CD] 10MG/100MG/ML INJECTABLE, For IV, IM, SC Use, 30 mL Multi-dose

D-0966-2020  ·  Class II  ·  reported 2020-03-11  ·  Terminated

Why it was recalled
Lack of Assurance of Sterility
Product
Methylcobalamin Injection, METHYLCOBALAMIN [CD] 10MG/100MG/ML INJECTABLE, For IV, IM, SC Use, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0338-3
Where it went
U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic
How much
N/A

Cyanocobalamin/Folinic Acid Injection, CYANOCOBALAMIN : FOLINIC ACID 2000 MCG/ML: 500MCG/ML INJECTABLE, For IV

D-0949-2020  ·  Class II  ·  reported 2020-03-11  ·  Terminated

Why it was recalled
Lack of Assurance of Sterility
Product
Cyanocobalamin/Folinic Acid Injection, CYANOCOBALAMIN : FOLINIC ACID 2000 MCG/ML: 500MCG/ML INJECTABLE, For IV, IM, SC Use, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0333-3
Where it went
U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic
How much
N/A

AscorbiX (Buffered C) Injection, Ascorbix (30ML) 500MG/ML Injectable, For IV, IM, SC Use, Refrigerate, 30 mL M

D-0939-2020  ·  Class II  ·  reported 2020-03-11  ·  Terminated

Why it was recalled
Lack of Assurance of Sterility
Product
AscorbiX (Buffered C) Injection, Ascorbix (30ML) 500MG/ML Injectable, For IV, IM, SC Use, Refrigerate, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0226-3
Where it went
U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic
How much
N/A

Dexamethasone (LA) Injectable Suspension, DEXAMETHASONE LA [10ML] 16MG INJ SUSP, For IM, IA Use, Shake Well,

D-0951-2020  ·  Class II  ·  reported 2020-03-11  ·  Terminated

Why it was recalled
Lack of Assurance of Sterility
Product
Dexamethasone (LA) Injectable Suspension, DEXAMETHASONE LA [10ML] 16MG INJ SUSP, For IM, IA Use, Shake Well, 10 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0630-1
Where it went
U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic
How much
N/A

Alprostadil/Papaverine Hydrochloride/Phentolamine Mesylate/Atropine Sulfate Injection, 40 mcg/25 mg/0.5mg/0.01

D-0933-2020  ·  Class II  ·  reported 2020-03-11  ·  Terminated

Why it was recalled
Lack of Assurance of Sterility
Product
Alprostadil/Papaverine Hydrochloride/Phentolamine Mesylate/Atropine Sulfate Injection, 40 mcg/25 mg/0.5mg/0.01mg/ml, For Intracavernosal Use, Freeze, 2.5 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0549-2
Where it went
U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic
How much
N/A

Cyanocobalamin Injection, CYANOCOBALAMIN 2000 MCG/ML INJECTABLE, For IV, IM, SC Use, 30 mL Multi-dose Vial,

D-0948-2020  ·  Class II  ·  reported 2020-03-11  ·  Terminated

Why it was recalled
Lack of Assurance of Sterility
Product
Cyanocobalamin Injection, CYANOCOBALAMIN 2000 MCG/ML INJECTABLE, For IV, IM, SC Use, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0330-3
Where it went
U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic
How much
N/A

Levocarnitine Injection, LEVOCARNITINE 500 MG/ML INJECTABLE, For IV Use, 30 mL Multi-dose Vial, Rx only, Axia

D-0961-2020  ·  Class II  ·  reported 2020-03-11  ·  Terminated

Why it was recalled
Lack of Assurance of Sterility
Product
Levocarnitine Injection, LEVOCARNITINE 500 MG/ML INJECTABLE, For IV Use, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-9260-3
Where it went
U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic
How much
N/A

Alprostadil/Papaverine Hydrochloride/Phentolamine Mesylate/Atropine Sulfate Injection, 18 mcg/1.8mg/0.2mg/0.02

D-0932-2020  ·  Class II  ·  reported 2020-03-11  ·  Terminated

Why it was recalled
Lack of Assurance of Sterility
Product
Alprostadil/Papaverine Hydrochloride/Phentolamine Mesylate/Atropine Sulfate Injection, 18 mcg/1.8mg/0.2mg/0.02mg/mL, For Intracavernosal Use, Freeze, 2.5 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0547-2
Where it went
U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic
How much
N/A

Lysine Hydrochloride Injection, LYSINE HCL 100MG/ML INJECTABLE, For IV, IM Use, 30 mL Multi-dose Vial, Rx on

D-0963-2020  ·  Class II  ·  reported 2020-03-11  ·  Terminated

Why it was recalled
Lack of Assurance of Sterility
Product
Lysine Hydrochloride Injection, LYSINE HCL 100MG/ML INJECTABLE, For IV, IM Use, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0342-3
Where it went
U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic
How much
N/A

Showing the 30 most recent of 64. 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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