CLASS II Drug recall · Reported 31 Jan 2024 · FDA Enforcement Report
Fosaprepitant for Injection 150 mg per vial recalled
BE Pharmaceuticals is recalling Fosaprepitant for Injection 150 mg per vial, Sterile lyophilized powder for Intravenous, distributed nationwide in the US. The recall was initiated on 10 Jan 2024 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-0262-2024
- FDA event ID
- 93747
- Recalling firm
- BE Pharmaceuticals, Zug, N/A
- Brand
- Fosaprepitant
- Manufacturer
- BE Pharmaceuticals Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 10 Jan 2024
- FDA classified
- 25 Jan 2024
- Reported
- 31 Jan 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Injectable & IV Drugs
Timeline
| 10 Jan 2024 | Recall initiated by company | |
| 25 Jan 2024 | Classified by FDA | +15 days |
| 31 Jan 2024 | 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
Lack of Sterility Assurance: Aseptic process simulation failure.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Fosaprepitant for Injection 150 mg per vial, Sterile lyophilized powder for Intravenous use only after reconstitution and dilution, Single Dose Vial, Rx Only, Distributed by BE Pharmaceuticals Inc. 203 New Edition Court Cary, NC 27511, Made in India, NDC 71839-104-01.
Where it was distributed
Nationwide in the USA
Questions about this recall
Why was it recalled?
Lack of Sterility Assurance: Aseptic process simulation failure.
Which lots are affected?
lot #13D012AA, Exp: 08/31/2025
Where was it sold?
Nationwide in the USA
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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from BE Pharmaceuticals
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Pantoprazole Sodium for Injection 40mg per vial, Single dose vials recalledPantoprazole Sodium | BE Pharmaceuticals | Sterility | Nationwide |
Other Fosaprepitant recalls
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Fosaprepitant for Injection, 150 mg / vial in a Single-Dose vial recalledFosaprepitant | Fresenius Kabi USA | Labeling Errors | Nationwide |
| Drug | CLASS II | Fosaprepitant 150 mg/ NS Ivpb recalled by Infusion Options | Infusion Options | Sterility | NY |