“Ingenus Leucovorin Calcium Injection Recall: Particulate Matter Risk.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/37863-ingenus-leucovorin-calcium-injection-recall-particulate-matter-risk. Based on FDA recall #D-0146-2020 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0146-2020%22&limit=1).
Ingenus Pharmaceuticals Llc recalled Leucovorin Calcium Injection, USP 500 mg*/50 mL (10 mg/mL) 50 mL Single-Dose Vial NDC 50742-464-50 due to crystallization hazards. The Food and Drug Administration announced the Class II recall on Oct. 9, 2019.
How to tell if you have it
Brand: Ingenus
Product: Leucovorin Calcium Injection, USP 500 mg*/50 mL (10 mg/mL) 50 mL Single-Dose Vial NDC 50742-464-50 Rx Only
The recall cites the presence of particulate matter identified as API crystallization. The FDA classified this as a Class II recall.
Context
GovInfoNow's records show Ingenus Pharmaceuticals Llc has four other recalls on record since June 8, 2018. Other recent recalls include an Ingenus Flunisolide Nasal Solution recall on Sept. 30, 2022, and an Ingenus Clobetasol Foam recall on Jan. 10, 2022. Similar product recalls include a Mallinckrodt Acthar Gel 5mL Vial recall on Aug. 6, 2026, and a Guardian Drug CAREone Calcium Antacid recall on May 28, 2026.
How to tell if you have this one
Check for vials labeled 'Leucovorin Calcium Injection, USP 500 mg/50 mL (10 mg/mL) 50 mL Single-Dose Vial NDC 50742-464-50'. Lot numbers 18048, 18049 (expiring April 2020) or 18050 (May 2020) or 19036 (December 2020).
Brand
Ingenus
Category
Drug
Based on the official FDA remedy
What to do — step by step
Stop Using Vial Now
Immediately discard the recalled vial if you have it.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “U.S.A. Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 14 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #D-0146-2020 (October 9, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0146-2020 to see it in context.
Plain-language summary written by qwen3:4b on October 5, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.