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.
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
By year reported
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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