Ferric Carboxymaltose Infusion Recalled for Lack of Sterility Assurance
Infusion Options, Inc. is recalling Ferric Carboxymaltose 750mg/50ml NS IVPB due to a lack of assurance of sterility. The product was 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 under the rubric, particularly given the risk of infection associated with a lack of sterility assurance in an intravenous product.
Plain-English summary
Infusion Options, Inc. is recalling Ferric Carboxymaltose 750mg/50ml NS IVPB, a prescription-only intravenous infusion product. The recall was initiated because of a lack of assurance of sterility.
The affected product was distributed in New York. The recall covers all lots within their expiration dates.
Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- FERRIC CARBOXYMALTOSE 750mg/50ml NS IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233
- Manufacturer
- Infusion Options, Inc.
- Category
- Drug — Intravenous 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