Rituxan Infusion (Infusion Options) – Sterility Risk (2019)
Class II: 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
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
RITUXAN 728 MG QS 728 mL 0.9% NACL IVPB; RITUXAN 560 MG / 306 ml 0.9% NACL; RITUXAN 562 MG IN 562 ml 0.9% NACL; RITUXAN 700 MG QS 700 mL 0.9% NACL IVPB; RITUXAN 1000 MG / 350 mL 0.9% NACL IVPB RITUXAN 730 MG / 730 mL 0.9% NACL IVPB; RITUXAN 1000 MG QS 1000 ml NS; RITUXAN 1000 MG QS 200 ml 0.9% NACL; RITUXAN 500 MG / 300 ml 0.9% NACL; RITUXAN 660 MG QS 660 ml 0.9% NACL; RITUXAN 770 MG QS 770 mL 0.9% NACL IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-28
Brand
Infusion Options, Inc.
Lot Codes / Batch Numbers
All lots within expiry
Products Sold
All lots within expiry
Infusion Options, Inc. is recalling RITUXAN 728 MG QS 728 mL 0.9% NACL IVPB; RITUXAN 560 MG / 306 ml 0.9% NACL; RITUXAN 562 MG IN 562 due to Lack of Assurance of Sterility. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Lack of Assurance of Sterility
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
NY
Page updated: Jan 7, 2026