Leucovorin Calcium Injection — Class II drug recall D-0146-2020
Terminated recall by Ingenus Pharmaceuticals Llc, reported 2019-10-23, distributed nationwide. Crystallization: Presence of particulate matter identified as API crystallization
| Recall number | D-0146-2020 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ingenus Pharmaceuticals Llc, Orlando, FL, United States |
| Recall initiated | 2019-10-09 |
| Classified | 2019-10-17 |
| Reported by FDA | 2019-10-23 |
| Terminated | 2020-12-01 |
| Distributed | Nationwide (US) |
| Quantity | 16,485 vials |
| Reason classes | specification failure |
| NDC | 50742-0464-50 |
| Lot numbers | 18048, 18049, 18050, 19036 |
| Expiration dates | 2020-04, 2020-05, 2020-12 |
Product
Leucovorin Calcium Injection, USP 500 mg*/50 mL (10 mg/mL) 50 mL Single-Dose Vial NDC 50742-464-50 Rx Only Ingenus Pharmaceuticals, LLC. Orlando, FL 32839
Reason for recall
Crystallization: Presence of particulate matter identified as API crystallization
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-0146-2020. 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.