Class III · Low risk
Sirolimus Tablets 1mg Tablets 100-count bottle
Failed Impurities/Degradation Specifications
Is Sirolimus recalled?
Yes — there is an active recall. 1 ongoing FDA recall mention Sirolimus (6 total). Check the affected lots below.
Most common reason: Impurity / degradation (3 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Sirolimus. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Sirolimus recalls on record
none so far in 2026; 6 on record, newest first
Class III · Low risk
Fyarro (albumin-bound)
Failed Stability Specifications
Class III · Low risk
Sirolimus Oral Solution
Failed Dissolution Specifications: Sirolimus Oral Solution recalled due to lot RZ1598 exceeded the specification limit at the 14-month timepoint.
Class III · Low risk
Sirolimus Tablets 1 mg
Failed Impurities/Degradation Specifications
Class III · Low risk
Sirolimus Tablets
Failed impurities/degradation: out of specification result for impurity secorapamycin.
Class II · Moderate risk
Sirolimus
Labeling: Label Mixup: SIROLIMUS, Tablet, 1 mg may be potentially mislabeled as one of the following drugs: PROPRANOLOL HCL, Tablet, 10 mg, NDC 23155011001, Pedigree: AD60272_34, EXP: 5/22/2014; HYDROCORTISONE, Tablet, 5 mg, NDC 00603389919, Pedigree: W003325, EXP: 6/18/2014.
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