Pharmcore Ipamorelin 3mg Vial Recall: Lack of Sterility Risk
Pharmcore recalls Ipamorelin 3mg lyophilized vials due to lack of sterility assurance. Affected lots expire July 2018. No remedy specified in official notice.
Recall notice
Lack of assurance of sterility.
Contact the company
What happened, in plain English
Pharmcore is recalling Ipamorelin 3mg lyophilized vials because they may not be sterile. This could lead to infections if used improperly. The recall covers specific lots with an expiration date of July 2018. Read more at govinfonow.com/recall/39821-pharmcore-ipamorelin-3mg-vial-recall-lack-of-sterility-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/39821-pharmcore-ipamorelin-3mg-vial-recall-lack-of-sterility-risk · Updated October 6, 2026 · FDA enforcement record: FDA #D-1153-2018
Cite this page
“Pharmcore Ipamorelin 3mg Vial Recall: Lack of Sterility Risk.” GovInfoNow, updated October 6, 2026. https://govinfonow.com/recall/39821-pharmcore-ipamorelin-3mg-vial-recall-lack-of-sterility-risk. Based on FDA recall #D-1153-2018 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1153-2018%22&limit=1).
Why it’s dangerous
The vials lack proper sterility assurance, meaning they could introduce harmful bacteria into the body when injected. This poses a risk of infection or other complications if used without proper sterilization.
Who’s affected
Users of the recalled Ipamorelin vials, particularly those in medical treatment programs. Patients receiving this medication for specific conditions are most at risk.
How to tell if you have this one
Check for the lot number IPA3-17 on the vial label. The vials were sold with an expiration date of July 2018. The product was manufactured by Pharmcore Inc. in Hallandale Beach, Florida.
- Brand
Pharmcore- Category
Drug
All 9 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
Nationwide
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-1147-2018 | Human Chorionic Gonadotropin 5000 IU Vial Lyophilized 1109 East Hallandale Beach Blvd. Hallandale Beach, FL 33009; Lots: HCG50319 Exp. 4/30/2019; HCG50316 Exp. 3/31/2019; HCG50317 Exp. 4/30/2019; HCG50315 Exp. 3/31/2019; HCG50318 Exp. 4/30/2019; HCG50320 Exp. 4/30/2019; HCG50321 Exp. 4/30/2019; HCG50311 Exp. 3/31/2019; HCG50310 Exp. 3/31/2019; HCG50309 Exp. 3/31/2019; HCG50313 Exp. 3/31/2019; HCG50314 Exp. 3/31/2019; | 5718 vials |
| D-1148-2018 | Human Chorionic Gonadotropin 11000 IU Vial Lyophilized 1109 East Hallandale Beach Blvd. Hallandale Beach, FL 33009; Lots: HCG1116 Exp. 3/31/2019; HCG1117 Exp. 4/30/2019 | 864 vials |
| D-1149-2018 | Human Chorionic Gonadotropin 20000 IU Vial Lyophilized 1109 East Hallandale Beach Blvd. Hallandale Beach, FL 33009; Lots: HCG22038 Exp. 3/31/2019; HCG22039 Exp. 4/30/2019 | 355 vials |
| D-1150-2018 | Human Chorionic Gonadotropin 2500 IU Vial Lyophilized 1109 East Hallandale Beach Blvd. Hallandale Beach, FL 33009; Lots: HCG25112 Exp. 2/28/2019; HCG25110 Exp. 1/31/2019; HCG25115 Exp. 4/30/2019; HCG25114 Exp. 4/30/2019; HCG25111 Exp. 2/28/2019 | 3070 vials |
| D-1151-2018 | Human Chorionic Gonadotropin 4000 IU Vial Lyophilized 1109 East Hallandale Beach Blvd. Hallandale Beach, FL 33009; Lots: HCG40160 Exp. 2/28/2019; HCG40161 Exp. 4/30/2019; HCG40159 Exp. 2/28/2019; HCG40162 Exp. 4/30/2019; HCG50308 Exp. 2/28/2019 | 2085 vials |
| D-1152-2018 | Human Chorionic Gonadotropin 6000 IU Vial Lyophilized 1109 East Hallandale Beach Blvd. Hallandale Beach, FL 33009; Lots: HCG60122 Exp. 4/30/2019; HCG60124 Exp. 6/30/2019; HCG60121 Exp. 4/30/2019; HCG60123 Exp. 5/31/2019; HCG60120 Exp. 4/30/2019; HCG60118 Exp. 2/28/2019; HCG1115 Exp. 1/31/2019 | 3351 vials |
| D-1153-2018 | Ipamorelin 3 mg Lyophilized 1 vial 1109 East Hallandale Beach Blvd. Hallandale Beach, FL 33009; Lot: IPA3-17 Exp. 07/2018 | 6 vials |
| D-1154-2018 | Methylcobalamin 10 mg vial Lyophilized 1109 East Hallandale Beach Blvd. Hallandale Beach, FL 33009; Lots: MTLY-19 Exp. 10/31/2018; MTLY-18 Exp. 8/31/2018 | 1115 vials |
| D-1155-2018 | Ipamorelin 9 mg vial Lyophilized 1109 East Hallandale Beach Blvd. Hallandale Beach, FL 33009; Lots: IPA9-15 Exp. 3/31/2019; IPA9-14 Exp. 1/31/2019 | 599 vials |
What to do — step by step
Check Vial Label
Look for the lot number IPA3-17 on the vial label to confirm if it is affected.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 3.5 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
Is this product safe to use?
The official recall notice states there is a lack of sterility assurance, so it is not safe to use as intended.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-1153-2018 (August 2, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1153-2018 to see it in context.
- Plain-language summary written by qwen3:4b on October 6, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.