Ganirelix recalls
The FDA has published 3 recalls involving Ganirelix since 2021. The latest was reported on 17 Dec 2025. Most were for sterility. Sun Pharmaceutical Industries has the most recalls in this group. Recalls usually affect specific lots, not every bottle on the market. Check the lot number on each recall page before acting.
Total recalls3since 2021
Last 12 months1reported
Class I00% of total
Ongoing1latest 17 Dec 2025
Recalls per month, last 24 months
click a bar for that monthSeverity split
Class I 0 0%Class II 3 100%Class III 0 0%
Why ganirelix is recalled
Companies
Brands
By year
Ongoing ganirelix recalls
1 active| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Ganirelix Acetate Injection, 250 mcg recalled by Lupin PharmaceuticalsGanirelix Acetate | Lupin Pharmaceuticals | Sterility | 4 states |
All ganirelix recalls, newest first
3 total| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Ganirelix Acetate Injection, 250 mcg recalled by Lupin PharmaceuticalsGanirelix Acetate | Lupin Pharmaceuticals | Sterility | 4 states |
| Drug | CLASS II | Fyremadel (ganirelix acetate) injection, 250 mcg recalledFyremadel | Sun Pharmaceutical Industries | Particulate Matter | Nationwide |
| Drug | CLASS II | Ganirelix Acetate Injection, 250 mcg/, Sterile Prefilled Syringe recalled | Sun Pharmaceutical Industries | Sterility | NJ |
Should you stop taking Ganirelix?
Not on your own. Most recalls affect specific lots from one manufacturer, and stopping a prescription suddenly can be riskier than the defect. Check your lot number and NDC against the recall, then call the pharmacy that dispensed it for a replacement.