Bevacizumab intravitreal syringes recalled for lack of sterility assurance
RC Outsourcing is recalling 2,669 prefilled Bevacizumab 1.75 mg/0.07 mL intravitreal syringes for lack of assurance of sterility.
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: Scored 3 under the risk-of-harm criterion: a loss of sterility assurance in an intravitreal injection creates an infection risk, and no injuries are reported.
Plain-English summary
Bevacizumab 1.75 mg/0.07 mL in 0.25 mL syringes for intravitreal use, 0.07 mL total volume, prescription only and for hospital or office use, from RC Outsourcing LLC of Lowellville, Ohio, is being recalled for lack of assurance of sterility.
The recall covers 2,669 syringes from lots 20250708-768A26 (beyond-use date 6 October 2025), 20250715-944DF2 (13 October 2025) and 20250722-55C603 (20 October 2025). The product was distributed nationwide in the United States. The FDA has classified the recall as Class II.
Sterility matters here because the product is injected directly into the eye. The enforcement record describes a loss of sterility assurance rather than confirmed contamination, and reports no injuries.
Facilities holding the affected lots should stop using them and follow the firm's instructions.
The recalled product
- 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.
- Manufacturer
- RC Outsourcing, LLC
- Category
- Drug — Injectable
- Affected units
- 2,669
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 (6)
- 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
Distribution
Distributed nationwide across the United States.
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