Leucovorin Calcium for Injection — Class II drug recall D-0737-2021
Terminated recall by Teva Pharmaceuticals USA, reported 2021-08-25, distributed nationwide. Lack of Assurance of Sterility
| Recall number | D-0737-2021 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Teva Pharmaceuticals USA, Parsippany, NJ, United States |
| Recall initiated | 2021-07-29 |
| Classified | 2021-08-16 |
| Reported by FDA | 2021-08-25 |
| Terminated | 2024-06-04 |
| Distributed | Nationwide (US) |
| Quantity | 434,229 vials |
| Reason classes | sterility |
| NDC | 00703-5145-01 |
| Lot numbers | 31325852B, 31325985B, 31326349B, 31326873B, 31326995B, 31327158B, 31328946B, 31329180B |
| Expiration dates | 2021-10, 2022-01, 2022-03, 2022-05, 2022-06, 2023-05 |
Product
Leucovorin Calcium for Injection, USP 350 mg/vial, 17.5 mL single-use vials, Rx only, Teva Parenteral Medicines, Inc. Irvine, CA 92618, NDC 0703-5145-01
Reason for recall
Lack of Assurance of Sterility
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-0737-2021. 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.