Romidepsin Injecton — Class III drug recall D-0309-2021
Terminated recall by Teva Pharmaceuticals USA, reported 2021-03-24, distributed nationwide. Failed Impurity/Degradation Specifications: Out-of-specifications results observed for impurities during stabi
| Recall number | D-0309-2021 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Teva Pharmaceuticals USA, Parsippany, NJ, United States |
| Recall initiated | 2021-03-04 |
| Classified | 2021-03-19 |
| Reported by FDA | 2021-03-24 |
| Terminated | 2022-05-19 |
| Distributed | Nationwide (US) |
| Quantity | 1,416 vials |
| Reason classes | specification failure |
| NDC | 00703-4004-01 |
| Lot numbers | 31327685C, 31327686C, 31328184C |
| Expiration dates | 2021-08, 2021-11 |
Product
Romidepsin Injecton, 27.5 mg/5.5 mL (5 mg/mL) Rx Only, 5.5 ml vial, Teva Pharmaceuticals USA, Inc. NDC 0703-4004-01
Reason for recall
Failed Impurity/Degradation Specifications: Out-of-specifications results observed for impurities during stability testing.
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-0309-2021. 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.