Sirolimus recalls

Sirolimus products have been recalled 4 times, most recently on 29 May 2024. The recalling company is usually Dr. Reddy's Laboratories. The most common reason is potency & assay.

Total recalls4since 2016

Last 12 months0reported

Class I00% of total

Ongoing1latest 29 May 2024

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 0 0 0Apr 0 0 0Jul 0 0 0Oct 0 0 0Jan '26 0 0 0Apr 0 0 0Jul 0 0

Severity split

Class I 0 0%Class II 0 0%Class III 4 100%

Why sirolimus is recalled

Potency & Assay4100%

Companies

By year

2024125%
2022125%
2021125%
2016125%

Ongoing sirolimus recalls

1 active

Reported	Class	Recall	Company	Reason	Where
29 May 2024Drug	CLASS III	Sirolimus Tablets 1mg Tablets recalled by Dr. Reddy's LaboratoriesSirolimus	Dr. Reddy's Laboratories	Potency & Assay	Nationwide

All sirolimus recalls, newest first

4 total

Reported	Class	Recall	Company	Reason	Where
29 May 2024Drug	CLASS III	Sirolimus Tablets 1mg Tablets recalled by Dr. Reddy's LaboratoriesSirolimus	Dr. Reddy's Laboratories	Potency & Assay	Nationwide
25 May 2022Drug	CLASS III	Sirolimus Oral Solution, 1 mg/mL recalled by ApotexSirolimus	Apotex	Potency & Assay	Nationwide
29 Sep 2021Drug	CLASS III	Sirolimus Tablets 1 mg (5 blister cards x doses) recalledSirolimus	American Health Packaging	Potency & Assay	Nationwide
13 Jul 2016Drug	CLASS III	Sirolimus Tablets, 1 mg recalled by Dr. Reddy's LaboratoriesSirolimus	Dr. Reddy's Laboratories	Potency & Assay	Nationwide

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.