Promise Pharmacy, LLC

Promise Pharmacy, LLC: 53 FDA recall reports

Every drug recall the FDA has published for Promise Pharmacy, LLC. The fault, and how the agency graded it.

53Reports
0Class I
0Ongoing
2021-09-22Most 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 II52
Class III1

By year reported

YearReports
20181
201951
20211
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.

MIC+Methyl B12 injection Methionine Inositol Choline+Methylcobalamin 25 mg/50 mg/50 mg/1 mg/mL, 10 mL vial ste

D-0803-2021  ·  Class II  ·  reported 2021-09-22  ·  Terminated

Why it was recalled
Lack of processing controls
Product
MIC+Methyl B12 injection Methionine Inositol Choline+Methylcobalamin 25 mg/50 mg/50 mg/1 mg/mL, 10 mL vial sterile, Rx only, Promise Pharmacy 31818 US Hwy 19N Palm Harbor FL 34684 1-888-3PROMIS
Where it went
AZ, CO, FL, IL, NJ
How much
57 vials

Acetylcysteine Ophthalmic Solution, 100mg/ml, 10%, Rx only, Promise Pharmacy Compounding Specialist, 31818 US

D-0431-2019  ·  Class II  ·  reported 2019-02-20  ·  Terminated

Why it was recalled
Lack of sterility assurance.
Product
Acetylcysteine Ophthalmic Solution, 100mg/ml, 10%, Rx only, Promise Pharmacy Compounding Specialist, 31818 US Hwy 19N, Palm Harbor FL 34684.
Where it went
Nationwide in the USA.
How much
75 10 ml bottles

Glycyrrhizic Acid, 8mg/mL Injection, 10ml vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy

D-0479-2019  ·  Class II  ·  reported 2019-02-20  ·  Terminated

Why it was recalled
Lack of sterility assurance.
Product
Glycyrrhizic Acid, 8mg/mL Injection, 10ml vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
Where it went
Nationwide in the USA.
How much
2 10ml vials

Zinc Sulfate, 5mg/mL injection, 10ml vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N,

D-0471-2019  ·  Class II  ·  reported 2019-02-20  ·  Terminated

Why it was recalled
Lack of sterility assurance.
Product
Zinc Sulfate, 5mg/mL injection, 10ml vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
Where it went
Nationwide in the USA.
How much
2 10 ml vials

Dexpanthenol, 250mg/mL Injection, 10ml vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 1

D-0478-2019  ·  Class II  ·  reported 2019-02-20  ·  Terminated

Why it was recalled
Lack of sterility assurance.
Product
Dexpanthenol, 250mg/mL Injection, 10ml vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
Where it went
Nationwide in the USA.
How much
7 vials

Thymosin Beta-4, 15 mg Injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Har

D-0447-2019  ·  Class II  ·  reported 2019-02-20  ·  Terminated

Why it was recalled
Lack of sterility assurance.
Product
Thymosin Beta-4, 15 mg Injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
Where it went
Nationwide in the USA.
How much
94 vials

Vitamin B Complex, Dexpanthenol/Leucine/Niacinamide/Pyridoxine/Riboflavin/Thiamine 2 mg/2.5 mg/25 mg/ 25 mg/ 2

D-0438-2019  ·  Class II  ·  reported 2019-02-20  ·  Terminated

Why it was recalled
Lack of sterility assurance.
Product
Vitamin B Complex, Dexpanthenol/Leucine/Niacinamide/Pyridoxine/Riboflavin/Thiamine 2 mg/2.5 mg/25 mg/ 25 mg/ 2 mg/ 25 mg/mL 10 mL vial, Rx Only, Compounded Prescription, Promise Pharmacy Compounding Specialists, 31818 US Hwy 19N, Palm Harbor FL 34684
Where it went
Nationwide in the USA.
How much
204 10 ml vials

BPC 157, 10mg injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 3

D-0459-2019  ·  Class II  ·  reported 2019-02-20  ·  Terminated

Why it was recalled
Lack of sterility assurance.
Product
BPC 157, 10mg injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
Where it went
Nationwide in the USA.
How much
37 vials

Ipamorelin+Modified GRF 1-29, 9 mg/5mg injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US H

D-0452-2019  ·  Class II  ·  reported 2019-02-20  ·  Terminated

Why it was recalled
Lack of sterility assurance.
Product
Ipamorelin+Modified GRF 1-29, 9 mg/5mg injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
Where it went
Nationwide in the USA.
How much
927 vials

Prednisolone and Gatifloxacin and Bromfenac, Ophthalmic Solution, 1%/0.5%/0.09%, Combo Drops 3 mL, Rx Only, Co

D-0436-2019  ·  Class II  ·  reported 2019-02-20  ·  Terminated

Why it was recalled
Lack of sterility assurance.
Product
Prednisolone and Gatifloxacin and Bromfenac, Ophthalmic Solution, 1%/0.5%/0.09%, Combo Drops 3 mL, Rx Only, Compounded Prescription, Promise Pharmacy 31818 US Hwy 19N, Palm Harbor FL 34684
Where it went
Nationwide in the USA.
How much
900 3 ml bottles

Folic Acid, 5mg/ml injection, 10ml vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, P

D-0481-2019  ·  Class II  ·  reported 2019-02-20  ·  Terminated

Why it was recalled
Lack of sterility assurance.
Product
Folic Acid, 5mg/ml injection, 10ml vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
Where it went
Nationwide in the USA.
How much
1 10 ml vial

Lysine HCl, 100 mg/mL injection, 10ml, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Pal

D-0477-2019  ·  Class II  ·  reported 2019-02-20  ·  Terminated

Why it was recalled
Lack of sterility assurance.
Product
Lysine HCl, 100 mg/mL injection, 10ml, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
Where it went
Nationwide in the USA.
How much
11 10 ml vials

MIC B12+L-Carnitine+Chromium injection, Methionine Inositol Choline Methylcobalamin+L-Carnitine+Chromium, 25mg

D-0467-2019  ·  Class II  ·  reported 2019-02-20  ·  Terminated

Why it was recalled
Lack of sterility assurance.
Product
MIC B12+L-Carnitine+Chromium injection, Methionine Inositol Choline Methylcobalamin+L-Carnitine+Chromium, 25mg/50mg/50mg/1mg/100mg/0.4mcg/ml, 10mL, injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
Where it went
Nationwide in the USA.
How much
64 vials

Multi Trace, Zinc/Copper/Manganese/Selenium 5mg/1mg/0.5mg/60mcg/ml, injection 30 mL, Rx Only, Compounded Presc

D-0439-2019  ·  Class II  ·  reported 2019-02-20  ·  Terminated

Why it was recalled
Lack of sterility assurance.
Product
Multi Trace, Zinc/Copper/Manganese/Selenium 5mg/1mg/0.5mg/60mcg/ml, injection 30 mL, Rx Only, Compounded Prescription, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
Where it went
Nationwide in the USA.
How much
3 30 ml vials

Prednisolone and Bromfenac Ophthalmic Solution, 1%/0.09% Combo Drops 3 mL, Rx Only, Compounded Prescription, P

D-0437-2019  ·  Class II  ·  reported 2019-02-20  ·  Terminated

Why it was recalled
Lack of sterility assurance.
Product
Prednisolone and Bromfenac Ophthalmic Solution, 1%/0.09% Combo Drops 3 mL, Rx Only, Compounded Prescription, Promise Pharmacy 31818 US Hwy 19N, Palm Harbor FL 34684
Where it went
Nationwide in the USA.
How much
167 3 ml bottles

Sermorelin, 15mg, injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor,

D-0463-2019  ·  Class II  ·  reported 2019-02-20  ·  Terminated

Why it was recalled
Lack of sterility assurance.
Product
Sermorelin, 15mg, injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
Where it went
Nationwide in the USA.
How much
266 vials

Prednisolone and Gatifloxacin and Ketorolac Ophthalmic Solution 1%/0.5%/0.5%, Combo Drops: 3 mL Rx Only, Compo

D-0434-2019  ·  Class II  ·  reported 2019-02-20  ·  Terminated

Why it was recalled
Lack of sterility assurance.
Product
Prednisolone and Gatifloxacin and Ketorolac Ophthalmic Solution 1%/0.5%/0.5%, Combo Drops: 3 mL Rx Only, Compounded Prescription, Promise Pharmacy 31818 US Hwy 19N, Palm Harbor FL 34684
Where it went
Nationwide in the USA.
How much
250 3 ml bottles

Ipamorelin, 9 mg injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, F

D-0453-2019  ·  Class II  ·  reported 2019-02-20  ·  Terminated

Why it was recalled
Lack of sterility assurance.
Product
Ipamorelin, 9 mg injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
Where it went
Nationwide in the USA.
How much
416 vials

Zinc Sulfate,10mg/ml injection, 10ml vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N,

D-0480-2019  ·  Class II  ·  reported 2019-02-20  ·  Terminated

Why it was recalled
Lack of sterility assurance.
Product
Zinc Sulfate,10mg/ml injection, 10ml vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
Where it went
Nationwide in the USA.
How much
3

Folic Acid, Injection, 10 mg/mL, 10mL vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N

D-0472-2019  ·  Class II  ·  reported 2019-02-20  ·  Terminated

Why it was recalled
Lack of sterility assurance.
Product
Folic Acid, Injection, 10 mg/mL, 10mL vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
Where it went
Nationwide in the USA.
How much
5 10ml vials

ICB-Complex, injection,Inositol/Choline/B1/B2/B3/B5/B6/B12/Leucine/Carnitine/Chromium/Lidocaine: 25mg/25mg/5mg

D-0466-2019  ·  Class II  ·  reported 2019-02-20  ·  Terminated

Why it was recalled
Lack of sterility assurance.
Product
ICB-Complex, injection,Inositol/Choline/B1/B2/B3/B5/B6/B12/Leucine/Carnitine/Chromium/Lidocaine: 25mg/25mg/5mg/2.5mg/25mg/5mg/5mg/0.1mg/1.5mg/25mg/25mg/10mg/ML, 10ml, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
Where it went
Nationwide in the USA.
How much
846 vials

Nicotinamide Adenine Dinucleotide, 0.5 mg, injection, 10mL vial, Rx Only, Promise Pharmacy Compounding Special

D-0468-2019  ·  Class II  ·  reported 2019-02-20  ·  Terminated

Why it was recalled
Lack of sterility assurance.
Product
Nicotinamide Adenine Dinucleotide, 0.5 mg, injection, 10mL vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
Where it went
Nationwide in the USA.
How much
5 10 mL vials

Epithalon, 15mg injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL

D-0457-2019  ·  Class II  ·  reported 2019-02-20  ·  Terminated

Why it was recalled
Lack of sterility assurance.
Product
Epithalon, 15mg injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
Where it went
Nationwide in the USA.
How much
30 vials

Ipamorelin, 15mg, injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor,

D-0455-2019  ·  Class II  ·  reported 2019-02-20  ·  Terminated

Why it was recalled
Lack of sterility assurance.
Product
Ipamorelin, 15mg, injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
Where it went
Nationwide in the USA.
How much
93 vials

IGF-1-LR3, 3 mg injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL

D-0464-2019  ·  Class II  ·  reported 2019-02-20  ·  Terminated

Why it was recalled
Lack of sterility assurance.
Product
IGF-1-LR3, 3 mg injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
Where it went
Nationwide in the USA.
How much
59 vials

Amino Blend Injection, Ornithine/Arginine/Lysine/Lidocaine 75 mg/75 mg/75 mg/10 mg/mL 10 mL, Rx Only, Promise

D-0444-2019  ·  Class II  ·  reported 2019-02-20  ·  Terminated

Why it was recalled
Lack of sterility assurance.
Product
Amino Blend Injection, Ornithine/Arginine/Lysine/Lidocaine 75 mg/75 mg/75 mg/10 mg/mL 10 mL, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
Where it went
Nationwide in the USA.
How much
158 10 ml vials

Sermorelin/GHRP2/GHRP6, 9 mg/9 mg/9 mg injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US H

D-0450-2019  ·  Class II  ·  reported 2019-02-20  ·  Terminated

Why it was recalled
Lack of sterility assurance.
Product
Sermorelin/GHRP2/GHRP6, 9 mg/9 mg/9 mg injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
Where it went
Nationwide in the USA.
How much
341 vials

Niacinamide injection, 100mg/mL, 5mL vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N,

D-0469-2019  ·  Class II  ·  reported 2019-02-20  ·  Terminated

Why it was recalled
Lack of sterility assurance.
Product
Niacinamide injection, 100mg/mL, 5mL vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
Where it went
Nationwide in the USA.
How much
1 vial

Ipamorelin+Sermorelin, 15mg/15mg, injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19

D-0454-2019  ·  Class II  ·  reported 2019-02-20  ·  Terminated

Why it was recalled
Lack of sterility assurance.
Product
Ipamorelin+Sermorelin, 15mg/15mg, injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
Where it went
Nationwide in the USA.
How much
139 vials

HCG, Human chorionic gonadotropin 2,000 units, injection, Rx Only, Promise Pharmacy Compounding Specialists 31

D-0462-2019  ·  Class II  ·  reported 2019-02-20  ·  Terminated

Why it was recalled
Lack of sterility assurance.
Product
HCG, Human chorionic gonadotropin 2,000 units, injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
Where it went
Nationwide in the USA.
How much
819 vials

Showing the 30 most recent of 53. 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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