Bevacizumab 1.75 mg/0.07 mL recall
FDA recall D-0003-2026 · initiated Sep 22, 2025
RC Outsourcing, LLC recalled Bevacizumab 1.75 mg/0.07 mL in Sep 2025 — an FDA Class II recall (D-0003-2026) because Lack of assurance of sterility.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Lack of assurance of sterility.
Sterility could not be assured
The maker could not guarantee the product was sterile. That matters most for injections and eye products, where a contaminated dose reaches past the body's defences.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 2,669 syringes
Details
- Product
- Bevacizumab 1.75 mg/0.07 mL - 0.25 mL syringe, Intravitreal, 0.07 mL Total Volume, Rx Only, Hospital/Office Use Only, Refrigerate, RC Outsourcing LLC, Lowellville, OH 44436.
- Recalling company
- RC Outsourcing, LLC
- Classification
- Class II
- Status
- Terminated
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide in the US
- Initiated
- Sep 22, 2025
- FDA report date
- Oct 15, 2025
Frequently asked
- Was Bevacizumab 1.75 mg/0.07 mL recalled?
- RC Outsourcing, LLC recalled Bevacizumab 1.75 mg/0.07 mL in Sep 2025 — an FDA Class II recall (D-0003-2026) because Lack of assurance of sterility. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Bevacizumab 1.75 mg/0.07 mL recalled?
- Per the FDA enforcement record, the reason for recall D-0003-2026 was: Lack of assurance of sterility.
- Is a recalled Bevacizumab 1.75 mg/0.07 mL dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Bevacizumab 1.75 mg/0.07 mL are affected?
- Distributed: Nationwide in the US. The recall covers these lots — Lot # 20250708-768A26, BUD: Oct 06, 2025 20250715-944DF2 BUD: Oct 13, 2025 20250722-55C603 BUD: Oct 20, 2025 20250722-5DC113 BUD: Oct 20, 2025. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0003-2026.