Azacitidine — Class III drug recall D-0576-2022
Terminated recall by Dr. Reddy's Laboratories, Inc., reported 2022-03-02, distributed nationwide. Failed stability specifications
| Recall number | D-0576-2022 |
|---|---|
| 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 | 2022-01-19 |
| Classified | 2022-02-22 |
| Reported by FDA | 2022-03-02 |
| Terminated | 2022-12-13 |
| Distributed | Nationwide (US) |
| Quantity | 18,261 vials |
| Reason classes | specification failure |
| NDC | 43598-0465, 43598-0465-62 |
| Lot numbers | H200107, H200154, H210020, H210055, H210129, H210288 |
| Expiration dates | 2023-08-01, 2023-09-01, 2023-11-01, 2023-12-01, 2024-01-01, 2024-04-01 |
Product
Azacitidine, 100mg/vial, One Single-dose Vial, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Visakhapatnam - 530 046, India, NDC 43598-465-62
Reason for recall
Failed stability 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-0576-2022. 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.