Fresenius Kabi Recalls Fosaprepitant Injection Due to Labeling Error
Fresenius Kabi USA, LLC is recalling 63,067 vials of Fosaprepitant for Injection because carton labels and product inserts incorrectly state the amount of the excipient edetate disodium (EDTA).
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences. The issue is a minor labeling error regarding an excipient.
Plain-English summary
Fresenius Kabi USA, LLC is recalling 63,067 vials of Fosaprepitant for Injection, 150 mg / vial in a 10 mL Single-Dose vial. The recall is due to a labeling error where the carton label and product insert incorrectly state the quantity of the excipient edetate disodium (EDTA) as 5.4 mg / vial, rather than the actual amount of 18.8 mg / vial.
The affected product is identified by NDC 63323-972-10. The recall includes vials from Lot # 6122760 and 6122761 (exp 08/2021), Lot # 6122762 (exp 09/2021), and Lot # 6123883 (exp 03/2022). The product was distributed nationwide within the United States.
This is a Class III recall, which indicates that the product is not likely to cause adverse health consequences. Consumers and healthcare providers should check their inventory for the specific lot numbers and expiration dates listed above.
The recalled product
- Product
- FOSAPREPITANT (FOSAPREPITANT)
- Brand
- FOSAPREPITANT
- Manufacturer
- Fresenius Kabi USA, LLC
- Category
- Drug — Prescription Drug
- Hazard
- Affected units
- 63,067
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 (7)
- Lot #: 6122760
- 6122761
- exp 08/2021
- 6122762
- exp 09/2021
- 6123883
- exp 03/2022
UPCs (1)
- 0363323972103
Distribution
Distributed nationwide across the United States.
Related recalls
Same brand · FOSAPREPITANT
- HighFDA Recalls Fosaprepitant Injection Due to Sterility Assurance Failure
FDA (Drugs) · 2024-01-31
Same manufacturer · Fresenius Kabi USA, LLC
See all →- SevereFresenius Kabi Recalls Tyenne Injection Due to Glass Particles
FDA (Drugs) · 2026-09-02
- CriticalFresenius Kabi Recalls Morphine Syringes Due to Labeling Error
FDA (Drugs) · 2026-08-26
- HighXylocaine Injection Recall Due to Hair Contamination
FDA (Drugs) · 2026-07-29
- ModerateGlycopyrrolate Injection Recall Due to Hair Contamination
FDA (Drugs) · 2026-07-29
- ModerateFDA Recalls Xylocaine Injections Due to Hair Contamination
FDA (Drugs) · 2026-07-29
Same hazard · mis labeling
See all →- ModerateOlympus Recalls PowerSeal Sealer Due to Incorrect Outer Box Labeling
FDA (Devices) · 2026-09-02
- ModerateAVID Medical Recalls Halyard Total Joint Kits for Latex Labeling Deficiency
FDA (Devices) · 2026-09-02
- HighByron White A-L Complex Herbal Supplement Recalled for Undeclared Walnut
FDA (Food) · 2026-09-02
- ModerateMedline Trach Tube Kit Recalled for Component Labeling Discrepancy
FDA (Devices) · 2026-09-02
- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-09-02