Lower risk Drug recall · FDA · Published August 24, 2021

Azurity Firvanq oral vancomycin kit recalled due to incorrect diluent component

Azurity Pharmaceuticals recalls Firvanq (vancomycin hydrochloride for oral solution) kits with incorrect diluent component. This may cause improper dosing. Consumers should contact the manufacturer for details.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-0003-2022Drug Azurity ›

Lower-risk recall

Product Mix-up: Incorrect diluent component included in the kit.

Take action

Contact the company

Recalling firmAzurity Pharmaceuticals, Inc.841 Woburn St · Wilmington, MA 01887-3414

✎ GovInfoNow plain-language explainer

Azurity Pharmaceuticals is recalling Firvanq oral vancomycin kits because they contain the wrong diluent component. This could lead to improper dosing of the medication, which may affect treatment effectiveness. Read more at govinfonow.com/recall/35883-azurity-firvanq-oral-vancomycin-kit-recalled-due-to-incorrect-diluent.

Source Summary by GovInfoNow · govinfonow.com/recall/35883-azurity-firvanq-oral-vancomycin-kit-recalled-due-to-incorrect-diluent · Updated August 18, 2026 · FDA enforcement record: FDA #D-0003-2022

Cite this page

“Azurity Firvanq oral vancomycin kit recalled due to incorrect diluent component.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/35883-azurity-firvanq-oral-vancomycin-kit-recalled-due-to-incorrect-diluent. Based on FDA recall #D-0003-2022 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0003-2022%22&limit=1).

The FDA announced on August 24, 2021, that Azurity Pharmaceuticals, Inc. voluntarily recalled Firvanq (vancomycin hydrochloride for oral solution) kits due to a product mix-up hazard. The recall affects 2,751 kits distributed nationwide.

How to tell if you have it

Brand: Azurity
Product: Firvanq (vancomycin hydrochloride for oral solution), Vancomycin 50 mg/mL Kit
NDC: 65628-206-05
Lot #: 21035
Expiration Date: 7/31/2022

The hazard

The hazard involves an incorrect diluent component included in the kit. The FDA classified this as a Class I recall.

Context

GovInfoNow's records show Azurity Pharmaceuticals, Inc. has 3 other recalls on record since 2023-02-15. Other recent recalls of similar products include Zenzedi 30mg Tablets Recall (2024-01-04), Azurity Eprontia oral solution recall (2023-12-08), and Azurity Testosterone Cypionate Injection Recall (2023-02-15). Other recent recalls of similar products include Baxter Vancomycin Injection Recall (2026-08-06) and Ajanta Pharma Fluphenazine Tablets Recall (2026-08-25).

How to tell if you have this one

Check for the kit label with NDC 65628-206-05, manufactured in Wilmington, MA, and lot number 21035. The product is for oral use only and requires a prescription.

Brand
Azurity
Category
Drug

Based on the official FDA remedy

What to do — step by step

Contact Manufacturer
Reach out to Azurity Pharmaceuticals for specific instructions on how to handle the recalled kit.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “USA nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 9 months after the firm started it.

Aug 24, 2021Firm started the recall
Oct 5, 2021FDA classified it Class I
Oct 13, 2021Published in FDA’s Enforcement Report
May 12, 2022FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/35883-azurity-firvanq-oral-vancomycin-kit-recalled-due-to-incorrect-diluent">Azurity Firvanq oral vancomycin kit recalled due to incorrect diluent component (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #D-0003-2022 (August 24, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0003-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.