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.
What this means for you
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
- Hazard
- sterility-failure
- contamination-risk
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.
Related recalls
Same category
- ModerateQuality Choice Earwax Removal Kit Carbamide Peroxide Subpotent Drug Recall
FDA (Drugs) · 2026-07-22
- ModerateNystatin Cream Recall Due to Low Potency Test Results
FDA (Drugs) · 2026-07-22
- SevereCleviprex Injectable Emulsion Recall Due to Sterility Assurance Concerns
FDA (Drugs) · 2026-07-22
- ModerateFamily Wellness Carbamide Peroxide Earwax Removal Kit Subpotent Drug
FDA (Drugs) · 2026-07-22
- ModerateFoster & Thrive Carbamide Peroxide 6.5% Recalled for Subpotent Strength
FDA (Drugs) · 2026-07-22