CLASS II Drug recall · Reported 3 May 2023 · FDA Enforcement Report
Fyremadel (ganirelix acetate) injection, 250 mcg recalled
Sun Pharmaceutical Industries is recalling Fyremadel (ganirelix acetate) injection, 250 mcg/, One Single Dose Sterile Prefilled, distributed nationwide in the US. The recall was initiated on 19 Apr 2023 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0569-2023
- FDA event ID
- 92140
- Recalling firm
- Sun Pharmaceutical Industries, Halol, N/A
- Brand
- Fyremadel
- Manufacturer
- Ferring Pharmaceuticals Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 19 Apr 2023
- FDA classified
- 10 May 2023
- Reported
- 3 May 2023
- Type
- N/A
- Customers notified by
- N/A
- Reason category
- Particulate Matter
- Drug class
- Injectable & IV Drugs
Timeline
| 19 Apr 2023 | Recall initiated by company | |
| 3 May 2023 | Published in enforcement report | +14 days |
| 10 May 2023 | Classified by FDA | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Presence of Particulate Matter: A piece of glass was found in a prefilled syringe.
Product as listed by the FDA
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
Where it was distributed
Nationwide in the USA
Questions about this recall
Why was it recalled?
Presence of Particulate Matter: A piece of glass was found in a prefilled syringe.
Which lots are affected?
Lot #: HAD1190A, Exp. 02/2024
Where was it sold?
Nationwide in the USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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Other Ganirelix recalls
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Ganirelix Acetate Injection, 250 mcg recalled by Lupin PharmaceuticalsGanirelix Acetate | Lupin Pharmaceuticals | Potency & Assay | 4 states |
| Drug | CLASS II | Ganirelix Acetate Injection, 250 mcg/, Sterile Prefilled Syringe recalled | SUN Pharmaceutical Industries | Potency & Assay | NJ |