Sirolimus recalls
The FDA has published 5 recalls involving Sirolimus since 2016. The latest was reported on 29 May 2024. Most were for potency & assay. Dr. Reddy's Laboratories 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 recalls5since 2016
Last 12 months0reported
Class I00% of total
Ongoing1latest 29 May 2024
Recalls per month, last 24 months
click a bar for that monthSeverity split
Class I 0 0%Class II 0 0%Class III 5 100%
Why sirolimus is recalled
Companies
Brands
By year
Ongoing sirolimus recalls
1 active| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Sirolimus Tablets 1mg Tablets recalled by Dr. Reddy's LaboratoriesSirolimus | Dr. Reddy's Laboratories | Potency & Assay | Nationwide |
All sirolimus recalls, newest first
5 total| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Sirolimus Tablets 1mg Tablets recalled by Dr. Reddy's LaboratoriesSirolimus | Dr. Reddy's Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS III | Fyarro (sirolimus protein-bound particles recalled by Aadi BioscienceFyarro | Aadi Bioscience | Particulate Matter | 4 states |
| Drug | CLASS III | Sirolimus Oral Solution, 1 mg/mL recalled by ApotexSirolimus | Apotex | Potency & Assay | Nationwide |
| Drug | CLASS III | Sirolimus Tablets 1 mg (5 blister cards x doses) recalledSirolimus | American Health Packaging | Potency & Assay | Nationwide |
| Drug | CLASS III | Sirolimus Tablets, 1 mg recalled by Dr. Reddy's LaboratoriesSirolimus | Dr. Reddy's Laboratories | Potency & Assay | Nationwide |
Should you stop taking Sirolimus?
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.