Infusion Options Recalls Leucovorin Infusions Due to Sterility Concerns
Infusion Options, Inc. is recalling various Leucovorin intravenous infusion bags due to a lack of assurance of sterility. The products were distributed in New York.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a Severe severity score (4) under the rubric, particularly given the risk of infection associated with a lack of sterility assurance in intravenous products.
Plain-English summary
Infusion Options, Inc. is recalling multiple lots of Leucovorin intravenous infusion bags (IVPB) in various concentrations and volumes. The recall was initiated because of a lack of assurance of sterility for these products.
The affected products include Leucovorin formulations in Normal Saline (NS) and Dextrose 5% in Water (D5W) solutions. The specific products listed include concentrations ranging from 300 mg to 840 mg in 250 ml or 50 ml volumes, as well as other specific combinations such as 314 mg/50 ml and 324 mg/50 ml. All lots within their expiry dates are affected.
These products were distributed only in New York. Infusion Options, Inc. is the recalling firm. Consumers and healthcare providers should stop using these products and contact the manufacturer or their healthcare provider for further instructions.
The recalled product
- Product
- LEUCOVORIN 560 MG / 250 ML NS IVPB; LEUCOVORIN 830 MG / 250 ml NS IVPB; LEUCOVORIN 300 MG / 50 ml D5W IVPB; LEUCOVORIN 840 MG / 250 ml NS IVPB; LEUCOVORIN 750 MG / 250 ml NS IVPB; LEUCOVORIN 690 MG / 250 ml NS IVPB; LEUCOVORIN 314 mg / 50 ml NS IVPB; LEUCOVORIN 620 MG / 250 ml D5
- Manufacturer
- Infusion Options, Inc.
- Category
- Drug — IV Infusion
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All lots within expiry
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 76 recalled by Infusion Options, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 76 products in this recall →Related recalls
Same manufacturer · Infusion Options, Inc.
See all →- SevereInfusion Options Recalls Calcium Glucunate IV Bags Due to Sterility Concerns
FDA (Drugs) · 2019-08-21
- SevereInfusion Options Recalls Durvalumab Infusions Due to Sterility Concerns
FDA (Drugs) · 2019-08-21
- SevereInfusion Options Recalls Rituximab Infusions Due to Sterility Concerns
FDA (Drugs) · 2019-08-21
- SevereInfusion Options Recalls Fluorouracil Infusions Due to Sterility Concerns
FDA (Drugs) · 2019-08-21
- SevereInfusion Options Recalls Velcade Syringes Due to Sterility Concerns
FDA (Drugs) · 2019-08-21
Same hazard · lack of sterility
See all →- HighRohto Cooling Eye Drops Max Strength Recalled Due to Sterility Concerns
FDA (Drugs) · 2026-07-29
- HighRohto Cooling Eye Drops Recalled Due to Lack of Assurance of Sterility
FDA (Drugs) · 2026-07-29
- SevereCleviprex Injectable Emulsion Recall Due to Sterility Assurance Concerns
FDA (Drugs) · 2026-07-22
- SeverePemetrexed for Injection recalled due to lack of sterility assurance
FDA (Drugs) · 2026-07-15
- SevereAzacitidine for Injection Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2026-07-15