Sirolimus Tablets 1mg Tablets 100-count bottle recall
FDA recall D-0504-2024 · initiated May 1, 2024
Dr. Reddy's Laboratories, Inc. recalled Sirolimus Tablets 1mg Tablets 100-count bottle in May 2024 — an FDA Class III recall (D-0504-2024) because Failed Impurities/Degradation Specifications.
Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
Why it was recalled
Failed Impurities/Degradation Specifications
An impurity above the accepted limit
A by-product of manufacturing or storage exceeded the limit the FDA accepts. Nitrosamines are the common example: the concern is long-term exposure, not immediate danger from one dose.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 1,176 bottles
Details
- 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
- Recalling company
- Dr. Reddy's Laboratories Limited
- Classification
- Class III
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- US Nationwide.
- Initiated
- May 1, 2024
- FDA report date
- May 29, 2024
Frequently asked
- Was Sirolimus Tablets 1mg Tablets 100-count bottle recalled?
- Dr. Reddy's Laboratories, Inc. recalled Sirolimus Tablets 1mg Tablets 100-count bottle in May 2024 — an FDA Class III recall (D-0504-2024) because Failed Impurities/Degradation Specifications. Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
- Why was Sirolimus Tablets 1mg Tablets 100-count bottle recalled?
- Per the FDA enforcement record, the reason for recall D-0504-2024 was: Failed Impurities/Degradation Specifications
- Is a recalled Sirolimus Tablets 1mg Tablets 100-count bottle dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. Unlikely to cause harm but violates FDA labeling or manufacturing regulations. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Sirolimus Tablets 1mg Tablets 100-count bottle are affected?
- Distributed: US Nationwide.. The recall covers these lots — Lot H2200493; Exp 6/30/2025. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0504-2024.