CLASS II Drug recall · Reported 23 Oct 2019 · FDA Enforcement Report
Leucovorin Calcium Injection, USP 500 mg* recalled
Ingenus Pharmaceuticals is recalling Leucovorin Calcium Injection, USP 500 mg*/ (10 mg/mL) Single-Dose Vial, distributed nationwide in the US. The recall was initiated on 9 Oct 2019 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0146-2020
- FDA event ID
- 84011
- Recalling firm
- Ingenus Pharmaceuticals, Orlando, FL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 9 Oct 2019
- FDA classified
- 17 Oct 2019
- Reported
- 23 Oct 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Particulate Matter
- Drug class
- Injectable & IV Drugs
Timeline
| 9 Oct 2019 | Recall initiated by company | |
| 17 Oct 2019 | Classified by FDA | +8 days |
| 23 Oct 2019 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Crystallization: Presence of particulate matter identified as API crystallization
Product as listed by the FDA
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
Where it was distributed
U.S.A. Nationwide
Questions about this recall
Is Leucovorin Calcium Injection, USP 500 mg*/ (10 mg/mL) Single-Dose Vial recalled?
Yes. Ingenus Pharmaceuticals recalled Leucovorin Calcium Injection, USP 500 mg*/ (10 mg/mL) Single-Dose Vial on 9 Oct 2019. The recall is Class II and its status is Terminated. Recall number D-0146-2020.
Why was it recalled?
Crystallization: Presence of particulate matter identified as API crystallization
Which lots are affected?
Lot#: 18048, 18049 Exp. 04/2020; 18050 Exp 05/2020; 19036 Exp 12/2020
Where was it sold?
U.S.A. Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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Other Leucovorin recalls
All 11| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Leucovorin Calcium for Injection, USP 100 mg/vial single-use vials recalled | Teva Pharmaceuticals U | Sterility | Nationwide |
| Drug | CLASS II | Leucovorin Calcium for Injection, USP 350 mg/vial single-use vials recalled | Teva Pharmaceuticals U | Sterility | Nationwide |
| Drug | CLASS II | Leucovorin Calcium for Injection, USP 350 mg/vial single-use vials recalled | Teva Pharmaceuticals U | Sterility | Nationwide |
| Drug | CLASS II | Leucovorin Calcium for Injection recalled by Teva Pharmaceuticals U | Teva Pharmaceuticals U | Sterility | Nationwide |
| Drug | CLASS II | Leucovorin Calcium for Injection, USP, 100 mg/vial, Single-Dose Vial recalled | Teva Pharmaceuticals U | Sterility | Nationwide |