Fyremadel — Class II drug recall D-0569-2023
Terminated recall by Sun Pharmaceutical Industries Ltd., reported 2023-05-03, distributed nationwide. Presence of Particulate Matter: A piece of glass was found in a prefilled syringe.
| Recall number | D-0569-2023 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Recalling firm | Sun Pharmaceutical Industries Ltd., Halol, N/A, India |
| Recall initiated | 2023-04-19 |
| Classified | 2023-05-10 |
| Reported by FDA | 2023-05-03 |
| Terminated | 2023-12-13 |
| Distributed | Nationwide (US) |
| Quantity | 24,194 prefilled |
| Reason classes | foreign material, specification failure |
| NDC | 55566-1010, 55566-1010-01 |
| Lot numbers | HAD1190A |
| Expiration dates | 2024-02 |
Product
Fyremadel (ganirelix acetate) injection, 250 mcg/0.5 mL, One Single Dose Sterile Prefilled Syringe 0.5 mL, For Subcutaneous Use, Rx Only, Sterile, Distributor: Ferring Pharmaceuticals Inc., Parsippany, NJ 07054, USA, NDC 55566-1010-1
Reason for recall
Presence of Particulate Matter: A piece of glass was found in a prefilled syringe.
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-0569-2023. 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.