Leucovorin Calcium for Injection — Class II drug recall D-0285-2021
Terminated recall by Teva Pharmaceuticals USA, reported 2021-03-03, distributed nationwide. Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for m
| Recall number | D-0285-2021 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Teva Pharmaceuticals USA, Parsippany, NJ, United States |
| Recall initiated | 2021-02-10 |
| Classified | 2021-02-21 |
| Reported by FDA | 2021-03-03 |
| Terminated | 2024-05-15 |
| Distributed | Nationwide (US) |
| Quantity | 705,745 vials |
| Reason classes | microbial contamination, sterility |
| NDC | 00703-5145-01 |
| Lot numbers | 31327396B |
| Expiration dates | 2021-02, 2021-03, 2021-07, 2021-11, 2022-02, 2022-08, 2022-10, 2022-11, 2022-12 |
Product
Leucovorin Calcium for Injection, USP, 350 mg/vial, Rx only, labeled as a) Teva Parenteral Medicines, Inc., Irvine, CA 92618, and b) Manufactured By: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, novaplus+, NDC 0703-5145-01.
Reason for recall
Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products.
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-0285-2021. 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.