Fulvestrant recalls
The FDA has published 2 recalls involving Fulvestrant since 2021. The latest was reported on 24 Aug 2022. Most were for sterility. Zydus Pharmaceuticals (USA) 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 recalls2since 2021
Last 12 months0reported
Class I00% of total
Ongoing0latest 24 Aug 2022
Recalls per month, last 24 months
click a bar for that monthSeverity split
Class I 0 0%Class II 2 100%Class III 0 0%
Why fulvestrant is recalled
Companies
By year
All fulvestrant recalls, newest first
2 total| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Fulvestrant Injection 250mg/ (50 mg/mL) recalledFulvestrant | Zydus Pharmaceuticals (USA) | Potency & Assay | Nationwide |
| Drug | CLASS II | Fulvestrant Injection 250 mg recalled by Glenmark PharmaceuticalsFulvestrant | Glenmark Pharmaceuticals Inc., U | Sterility | Nationwide |
Should you stop taking Fulvestrant?
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.