FDA Recalls Fosaprepitant Injection Due to Sterility Assurance Failure
BE Pharmaceuticals recalls Fosaprepitant for Injection nationwide due to failed aseptic process validation. The 22,176 vials from lot #13D012AA may lack sterility assurance.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall for a sterile injectable drug where the aseptic process simulation failed, creating potential contamination risk. No illnesses or injuries have been reported, making the hazard theoretical. Per the rubric, this qualifies as a risk-of-harm product without reported injury, warranting a score of 3 (High).
Plain-English summary
Fosaprepitant for Injection 150 mg, manufactured by BE Pharmaceuticals AG and distributed nationwide, is being recalled. The recall affects 22,176 vials from lot #13D012AA (expiration 08/31/2025). The drug is used to prevent nausea and vomiting in patients receiving chemotherapy.
The recall was initiated due to lack of sterility assurance. An aseptic process simulation—a critical manufacturing test—failed to validate that the sterilization process meets required standards. This failure creates a potential risk that some vials may not be sterile.
Healthcare providers who received this product should quarantine the affected lot and return it to the manufacturer or their pharmaceutical distributor. Patients should not use vials from this lot and should consult their healthcare provider if they have questions about their medication.
The recalled product
- Product
- FOSAPREPITANT (FOSAPREPITANT)
- Brand
- FOSAPREPITANT
- Manufacturer
- BE PHARMACEUTICALS AG
- Category
- Drug — Intravenous Injectable
- Affected units
- 22,176
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 (2)
- lot #13D012AA
- Exp: 08/31/2025
UPCs (1)
- 0371839104017
Distribution
Distributed nationwide across the United States.
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