Ipamorelin Acetate/Sermorelin Acetate — Class II drug recall D-0777-2022
Terminated recall by North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding, reported 2022-04-27, distributed nationwide. Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into que
| Recall number | D-0777-2022 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding, Richardson, TX, United States |
| Recall initiated | 2022-04-05 |
| Classified | 2022-04-21 |
| Reported by FDA | 2022-04-27 |
| Terminated | 2023-10-05 |
| Distributed | Nationwide (US) |
| Quantity | 189 vials |
| Reason classes | sterility, cgmp |
| Lot numbers | 32961 |
| Expiration dates | 2022-05-12 |
Product
Ipamorelin Acetate/Sermorelin Acetate (1 mg/1 mg)/mL (10 mL) Injection, 10 mL vials, Rx Only, Farmakeio 1736 N Greenville Ave Richardson, TX 75081
Reason for recall
Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0777-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.