Sirolimus recalls: 5 FDA reports
Recalls involving Sirolimus. What was wrong with each batch, and how the FDA graded the risk.
5Reports
0Class I
1Ongoing
2024-05-29Most recent
What the classes mean
The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.
Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.
By class
By year reported
Checking whether it affects you
The lot or code number is what matters. Not the product name. A recall covers
specific lots. Yours may not be one of them.
Check the code on your package against the report. The FDA keeps the current
list at fda.gov/safety/recalls.
The reports
The text below is quoted from the FDA record word for word.
Sirolimus Tablets 1mg Tablets 100-count bottle, Rx Only, Distributed by: Dr. Reddy's Laboratories Inc., Prince
D-0504-2024 · Class III · reported 2024-05-29 · Ongoing
- Why it was recalled
- Failed Impurities/Degradation Specifications
- Product
- Sirolimus Tablets 1mg Tablets 100-count bottle, Rx Only, Distributed by: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC 55111-653-01
- Where it went
- US Nationwide.
- How much
- 1,176 bottles
Fyarro (sirolimus protein-bound particles for injectable suspension (albumin-bound), 100 mg per vial, NDC 8080
D-0059-2023 · Class III · reported 2022-11-23 · Terminated
- Why it was recalled
- Failed Stability Specifications
- Product
- Fyarro (sirolimus protein-bound particles for injectable suspension (albumin-bound), 100 mg per vial, NDC 80803-153-50, manufactured for Aadi Bioscience, Inc, CA.
- Where it went
- Within the U.S Market - PA, AL, KY, TN
- How much
- 2,333 vials
Sirolimus Oral Solution, 1 mg/mL, 60 mL bottle, Rx Only, Manufactured by: Apotex Inc. Toronto, Ontario Canada
D-0881-2022 · Class III · reported 2022-05-25 · Terminated
- Why it was recalled
- Failed Dissolution Specifications: Sirolimus Oral Solution recalled due to lot RZ1598 exceeded the specification limit at the 14-month timepoint.
- Product
- Sirolimus Oral Solution, 1 mg/mL, 60 mL bottle, Rx Only, Manufactured by: Apotex Inc. Toronto, Ontario Canada M9L 1T9 Manufactured for: Apotex Corp. Weston, Florida 33326, NDC 60505-6197-2
- Where it went
- Nationwide in the USA
- How much
- 2353 bottles
Sirolimus Tablets 1 mg, 30 Tablets (5 blister cards x 6 unit doses), Rx only, Packaged and Distributed by: Ame
D-0813-2021 · Class III · reported 2021-09-29 · Terminated
- Why it was recalled
- Failed Impurities/Degradation Specifications
- Product
- Sirolimus Tablets 1 mg, 30 Tablets (5 blister cards x 6 unit doses), Rx only, Packaged and Distributed by: American Health Packaging Columbus, OH 43217, NDC 68084-915-25
- Where it went
- Nationwide within the USA
- How much
- 290 cartons
Sirolimus Tablets, 1 mg, 100-count bottle, Rx only, Manufactured by: Dr. Reddy's Laboratories Limited, Visakha
D-1063-2016 · Class III · reported 2016-07-13 · Terminated
- Why it was recalled
- Failed impurities/degradation: out of specification result for impurity secorapamycin.
- Product
- Sirolimus Tablets, 1 mg, 100-count bottle, Rx only, Manufactured by: Dr. Reddy's Laboratories Limited, Visakhapatnam - 5300046 India, NDC 55111-653-01
- Where it went
- Nationwide
- How much
- 9,330 bottles
Read these counts with three things in mind
A firm with more recalls usually makes more products. A contract packer runs
hundreds of lines. It will out-recall a company with one product whatever either
does. This is not a safety ranking.
Most recalls here are voluntary. A firm found its own fault and pulled the stock.
That is the system working. It lands in this database looking the same as a recall
the FDA had to push for.
Terminated means the FDA considers the recall finished. It is not a verdict.
It does not mean anyone was harmed.
Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.
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