Sirolimus Tablets 1mg Tablets 100-count bottle — Class III drug recall D-0504-2024
Ongoing recall by Dr. Reddy's Laboratories, Inc., reported 2024-05-29, distributed nationwide. Failed Impurities/Degradation Specifications
| Recall number | D-0504-2024 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Dr. Reddy's Laboratories, Inc., Princeton, NJ, United States |
| Recall initiated | 2024-05-01 |
| Classified | 2024-05-21 |
| Reported by FDA | 2024-05-29 |
| Distributed | Nationwide (US) |
| Quantity | 1,176 bottles |
| Reason classes | specification failure |
| NDC | 55111-0653, 55111-0653-01, 55111-0653-30, 55111-0654, 55111-0654-01, 55111-0654-30 |
| Lot numbers | H2200493 |
| Expiration dates | 2025-06-30 |
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
Reason for recall
Failed Impurities/Degradation Specifications
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0504-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.