Firvanq Vancomycin (Azurity) – Product Mix-up (2021)
Class I: A situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death
Class I recall indicates potential for serious health consequences.
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
Firvanq (vancomycin hydrochloride for oral solution), Vancomycin 50 mg/mL Kit, Each Kit Includes: 1 bottle containing 7.7 g Vancomycin Hydrochloride USP, powder for oral solution and 1 bottle containing 145 mL Grape Flavored Diluent for reconstitution per carton, Rx only, Manufactured for: Azurity pharmaceuticals, Wilmington, MA 01887, NDC 65628-206-05.
Brand
Azurity Pharmaceuticals, Inc.
Lot Codes / Batch Numbers
Lot # 21035, Exp 7/31/2022
Products Sold
Lot # 21035, Exp 7/31/2022
Azurity Pharmaceuticals, Inc. is recalling Firvanq (vancomycin hydrochloride for oral solution), Vancomycin 50 mg/mL Kit, Each Kit Includes: 1 due to Product Mix-up: Incorrect diluent component included in the kit.. 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
Product Mix-up: Incorrect diluent component included in the kit.
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 noticePage updated: Jan 7, 2026