Innoveix Compounded Semorelin/Ipamorelin 3mg Recall: Lack of Sterility Assurance
Innoveix Pharmaceuticals recalls compounded semorelin/ipamorelin 3mg injections due to lack of sterility assurance. This could lead to infections if used improperly. Affected lots expired by January 2022.
Recall notice
Lack of Assurance of Sterility
Contact the company
What happened, in plain English
Innoveix Pharmaceuticals is recalling compounded semorelin/ipamorelin 3mg injections because they may not be sterile. Using these products could cause infections, especially since they are prescription-only medications. Read more at govinfonow.com/recall/36097-innoveix-compounded-semorelin-ipamorelin-3mg-recall-lack-of-sterility-assurance.
Source Summary by GovInfoNow · govinfonow.com/recall/36097-innoveix-compounded-semorelin-ipamorelin-3mg-recall-lack-of-sterility-assurance · Updated August 18, 2026 · FDA enforcement record: FDA #D-0692-2021
Cite this page
“Innoveix Compounded Semorelin/Ipamorelin 3mg Recall: Lack of Sterility Assurance.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/36097-innoveix-compounded-semorelin-ipamorelin-3mg-recall-lack-of-sterility-assurance. Based on FDA recall #D-0692-2021 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0692-2021%22&limit=1).
Why it’s dangerous
The products lack sterility assurance, meaning they might contain harmful bacteria or other contaminants. This could lead to infections when injected, particularly since these are prescription medications used for specific medical conditions.
Who’s affected
Prescription patients who received these compounded injections from Innoveix in the specified lots. Those with medical conditions requiring these hormones are at higher risk.
How to tell if you have this one
Check for lot numbers SIP215 (expires 01/14/2022), SIP220 (expires 01/23/2022), or SIP210 (expires 12/15/2021) on the product label. These were compounded by Innoveix in Texas.
- Brand
Innoveix- Category
Drug
All 2 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
Completed- Distribution
Nationwide within the United States
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-0692-2021 | Compounded Lyophilized Semorelin/Ipamorelin 3 mg For subcutaneous or intramuscular injection, Rx Only, Compounded by: Innoveix Addison, TX 75001 800-370-1910; Lot #: SIP215 Exp. 01/14/2022, SIP220 Exp. 01/23/2022, SIP210 Exp. 12/15/2021 | 728 vials |
| D-0693-2021 | Compounded Lyophilized AOD-9604, 3 mg For subcutaneous or intramuscular injection, Rx Only, Compounded by: Innoveix Addison, TX 75001 800-370-1910; Lot #: AOD205 Exp. 11/09/2021; AOD210 Exp. 11/18/2021; AOD215 Exp. 12/15/2021; AOD220 Exp. 01/20/2022. | 1,316 vials |
What to do — step by step
Check Product Label
Look for lot numbers SIP215, SIP220, or SIP210 on the product label.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide within the United States” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 19 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
Questions people ask
Is this product safe to use?
The recall states there is a lack of sterility assurance, so these products may not be safe. Do not use them until you contact Innoveix.
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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-0692-2021 (July 9, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0692-2021 to see it in context.
- Plain-language summary written by qwen3:4b on August 18, 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.