Leiter's Pharmacy Recalls Bevacizumab Syringes Due to Sterility Concerns
Leiter's Pharmacy is recalling 265 vials of compounded Bevacizumab (Avastin) because a testing lab reported failed sterility results as passing, making the product's sterility unassured.
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 and involves a sterility failure in an injectable drug, which poses a risk of serious infection or adverse health consequences, meeting the criteria for a Severe rating.
Plain-English summary
Leiter's Compounding Pharmacy is recalling 265 vials of Bevacizumab (Avastin) 2.5mg/0.1mL PF Inj., 0.1 mL syringe. The product was compounded by Leiter's Pharmacy in San Jose, California, and distributed nationwide. The specific lot numbers involved are 08052013@1 and 08052013@4, with an expiration date of 11/03/2013.
The recall was initiated due to a lack of assurance of sterility. An investigation revealed that a contract testing laboratory reported out-of-specification (OOS) or failed sterility results to customers as passing. Consequently, the sterility of the recalled products cannot be assured.
Patients who have received this medication should contact their healthcare provider for guidance. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Bevacizumab (Avastin) 2.5mg/0.1mL PF Inj., 0.1 mL syringe, Compounded by Leiter's Compounding Pharmacy, 1700 Park Ave., # 30, San Jose, CA 95126
- Manufacturer
- Leiter's Pharmacy
- Category
- Drug — Compounded Injectable
- Affected units
- 265
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 (3)
- Lot #: 08052013@1
- 08052013@4
- Exp 11/03/2013
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by Leiter's Pharmacy 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 4 products in this recall →Related recalls
Same manufacturer · Leiter's Pharmacy
See all →- SevereLeiter's Pharmacy Recalls Lidocaine/Phenylephrine Vials Due to Sterility Concerns
FDA (Drugs) · 2013-09-25
- SevereLeiter's Pharmacy Recalls Dextrose 50% Injection Vials Due to Sterility Concerns
FDA (Drugs) · 2013-09-25
- SevereLeiter's Pharmacy Recalls Hyaluronidase Vials Due to Sterility Concerns
FDA (Drugs) · 2013-09-25
Same hazard · sterility failure
See all →- SevereROHTO DIGI-EYE Eye Drops Recalled Over Sterility Assurance Gap
FDA (Drugs) · 2026-07-29
- HighROHTO DRY-AID Eye Drops Recalled Due to Sterility Concerns
FDA (Drugs) · 2026-07-29
- SevereTransvenous Pacing Electrode Tray with Bipolar Balloon Pacing Electrode Recalled
FDA (Devices) · 2026-07-22
- SevereArterial Line Kit with Lidocaine HCL Injection Fails Sterility Testing
FDA (Devices) · 2026-07-22
- SevereOne-Piece Introducer Tray kits recalled for sterility failure
FDA (Devices) · 2026-07-22