Use caution Drug recall · FDA · Published November 25, 2019

AuroMedics Recalls Vancomycin Injection Due to Discoloration

AuroMedics Pharma LLC recalls specific lots of Vancomycin Hydrochloride for Injection due to product complaints of discoloration after reconstitution.

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

🇺🇸 FDA recall #D-0574-2020Drug AuroMedics Pharma ›

Use caution until it’s fixed

Discoloration: Product complaints of discoloration after reconstitution of vials.

Take action

Contact the company

Recalling firmAuroMedics Pharma LLC279 Princeton Hightstown Rd · East Windsor, NJ 08520-1401

✎ GovInfoNow plain-language explainer

AuroMedics Pharma LLC is recalling Vancomycin Hydrochloride for Injection, USP, 1 g per vial, because of complaints regarding discoloration after the drug is reconstituted. The recall affects 275,060 vials distributed nationwide in the USA. The record does not specify a remedy or action steps for consumers. Read more at govinfonow.com/recall/37670-auromedics-recalls-vancomycin-injection-due-to-discoloration.

Source Summary by GovInfoNow · govinfonow.com/recall/37670-auromedics-recalls-vancomycin-injection-due-to-discoloration · Updated October 11, 2026 · FDA enforcement record: FDA #D-0574-2020

Cite this page

“AuroMedics Recalls Vancomycin Injection Due to Discoloration.” GovInfoNow, updated October 11, 2026. https://govinfonow.com/recall/37670-auromedics-recalls-vancomycin-injection-due-to-discoloration. Based on FDA recall #D-0574-2020 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0574-2020%22&limit=1).

The FDA announced on 2019-11-25 that AuroMedics Pharma LLC voluntarily recalled Vancomycin Hydrochloride for Injection due to discoloration after reconstitution. The recall affects 275,060 vials distributed nationwide.

How to tell if you have it

Brand: AuroMedics Pharma
Product: Vancomycin Hydrochloride for Injection, USP, 1 g* per vial
Packaging: 10-count vials per carton
NDC: 55150-204-20
Lot codes: CVM180003 (Exp 04/2020), CVM180004 (Exp 04/2020), CVM180008 (Exp 07/2020), CVM180009, CVM180010, CVM180011, CVM180012 (Exp 09/2020)
Distribution: Nationwide in the USA

The hazard

The product complaints involve discoloration after reconstitution of vials. The FDA classified this as a Class II recall.

Context

GovInfoNow's records show AuroMedics Pharma LLC has 22 other recalls on record since 2017-12-04. Other recent recalls include an AuroMedics Fondaparinux Injection recall for subpotent drug risk (2022-09-30), an AuroMedics Tranexamic Acid Injection recall for metal particulate hazard (2022-09-26), and an AuroMedics Acyclovir Injection recall for particulate matter hazard (2022-09-26). Other recent recalls of similar products include a Baxter Vancomycin Injection recall for CGMP deviations in single-dose containers (2026-08-06), another Baxter Vancomycin Injection recall for CGMP deviations risk (2026-08-06), and a Fagron Vancomycin Injection recall for blue break-off-part risk (2026-03-20).

How to tell if you have this one

Check if you have Vancomycin Hydrochloride for Injection, USP, 1 g per vial, packaged in 10-count cartons. Look for NDC 55150-204-20 and the following lot numbers: CVM180003, CVM180004 (Exp 04/2020); CVM180008 (Exp 07/2020); CVM180009, CVM180010, CVM180011, CVM180012 (Exp 09/2020).

Brand
AuroMedics Pharma
Category
Drug

Based on the official FDA remedy

What to do — step by step

Check Lot Numbers
Verify if your vials match the recalled lot numbers and expiration dates listed in the record.
Contact Healthcare Provider
Consult with your doctor or pharmacist regarding the specific lots and any necessary steps for replacement or disposal.

Where it went and when

Where it was distributed

Distributed nationwide.

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

Distributed nationwide.

Recall timeline

FDA terminated this recall 15 months after the firm started it.

Nov 25, 2019Firm started the recall
Dec 6, 2019FDA classified it Class II
Dec 18, 2019Published in FDA’s Enforcement Report
Mar 4, 2021FDA terminated the recall

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

Similar recalls

Latest drug recalls

Keep exploring

Link to this recall

<a href="https://govinfonow.com/recall/37670-auromedics-recalls-vancomycin-injection-due-to-discoloration">AuroMedics Recalls Vancomycin Injection Due to Discoloration (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-0574-2020 (November 25, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0574-2020 to see it in context.
Plain-language summary written by qwen3.6:35b-a3b on October 11, 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.