Sirolimus Tablets — Class III drug recall D-1063-2016
Terminated recall by Dr. Reddy's Laboratories, Inc., reported 2016-07-13, distributed nationwide. Failed impurities/degradation: out of specification result for impurity secorapamycin.
| Recall number | D-1063-2016 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Dr. Reddy's Laboratories, Inc., Princeton, NJ, United States |
| Recall initiated | 2016-06-03 |
| Classified | 2016-07-05 |
| Reported by FDA | 2016-07-13 |
| Terminated | 2017-04-07 |
| Distributed | Nationwide (US) |
| Quantity | 9,330 bottles |
| Reason classes | specification failure |
| NDC | 55111-0653, 55111-0653-01, 55111-0653-30, 55111-0654, 55111-0654-01, 55111-0654-30 |
| Lot numbers | 07/16, 08/16, 10/16, 11/16, H400044, H400045, H400048, H400055, H400070, H400071, H400073, H400074 |
Product
Sirolimus Tablets, 1 mg, 100-count bottle, Rx only, Manufactured by: Dr. Reddy's Laboratories Limited, Visakhapatnam - 5300046 India, NDC 55111-653-01
Reason for recall
Failed impurities/degradation: out of specification result for impurity secorapamycin.
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-1063-2016. 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.