Sermorelin Acetate — Class II drug recall D-0592-2018
Terminated recall by American Pharmaceutical Ingredients LLC, reported 2018-03-21, distributed nationwide. Stability Data Does Not Support Expiry: Stability data from manufacturer does not support expiration dates lis
| Recall number | D-0592-2018 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | American Pharmaceutical Ingredients LLC, Waterford, MI, United States |
| Recall initiated | 2018-03-07 |
| Classified | 2018-03-12 |
| Reported by FDA | 2018-03-21 |
| Terminated | 2019-12-02 |
| Distributed | Nationwide (US) |
| Quantity | 1,460 gm |
| Reason classes | specification failure |
| NDC | 58597-8092-01, 58597-8092-02, 58597-8092-04 |
| Lot numbers | 011917C-1, 071916-1, 080516-1, 080516-2, 101216-1 |
| Expiration dates | 2018-07-08, 2018-07-22, 2018-09-15 |
Product
Sermorelin Acetate, powder, a) 1 GM-bottle (NDC58597-8092-1) b) 5 GM-bottle (NDC 58597-8092-2) c) 10 GM-bottle (NDC 58597-8092-4) API American Pharmaceutical Ingredients
Reason for recall
Stability Data Does Not Support Expiry: Stability data from manufacturer does not support expiration dates listed.
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-0592-2018. 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.