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Class III · Lower riskActive recall

Sirolimus

Unlikely to cause harm — often a labeling or packaging issue.

Does this affect you?
Check your lot numberLot H2200493; Exp 6/30/2025
Where it was soldUS Nationwide.
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

Failed Impurities/Degradation Specifications

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byMade in India foreign manufacturer
Brand nameSIROLIMUS
Generic nameSIROLIMUS
Active ingredient(s)SIROLIMUS
Distributed by / forDr. Reddy's Laboratories Inc., Princeton, NJ 08540
NDC55111-653-01
Show the full FDA record
Full product labelSirolimus 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
Recalling firmDr. Reddy's Laboratories, Inc.
DistributionUS Nationwide.
Quantity1,176 bottles
Recall initiated2024-05-01
Report date2024-05-29
Recall completed—
Recall numberD-0504-2024
ClassificationClass III
FDA statusOngoing
Origin on filePrinceton NJ United States

Related

Recent drug recallsCheck another medication

Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.