Lower risk Drug recall · FDA · Published November 11, 2019

AuroMedics Amiodarone Injection Recall: Crystallization Risk

AuroMedics Pharma recalls 150mg/3mL Amiodarone injection vials due to visible crystallization. This may cause blockages or reactions. Check NDC 55150-180-03, Lot# CAH180009, exp. Feb 2020.

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

🇺🇸 FDA recall #D-0520-2020Drug AuroMedics ›

Lower-risk recall

Crystallization: Presence of visible particulate matter.

Take action

Contact the company

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

✎ GovInfoNow plain-language explainer

AuroMedics Pharma recalls specific Amiodarone injection vials because they may contain visible crystallization. This could cause blockages or reactions in the body. Only prescription medication, so affected individuals should contact their doctor. Read more at govinfonow.com/recall/37739-auromedics-amiodarone-injection-recall-crystallization-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/37739-auromedics-amiodarone-injection-recall-crystallization-risk · Updated October 5, 2026 · FDA enforcement record: FDA #D-0520-2020

Cite this page

“AuroMedics Amiodarone Injection Recall: Crystallization Risk.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/37739-auromedics-amiodarone-injection-recall-crystallization-risk. Based on FDA recall #D-0520-2020 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0520-2020%22&limit=1).

AuroMedics Pharma LLC recalled Amiodarone Hydrochloride Injection, USP, 150 mg per 3 mL vials due to crystallization and visible particulate matter, the FDA said on Nov. 11, 2019.

How to tell if you have it

Brand: AuroMedics
Product: Amiodarone Hydrochloride Injection, USP, 150 mg per 3 mL (50 mg / mL), 3 mL Single Dose Vial
NDC: 55150-180-03
Lot#: CAH180009
Expiration date: Feb 2020
Quantity: 28,810 vials

The hazard

The recall addresses the presence of visible particulate matter caused by crystallization in the injection vials.

Context

GovInfoNow's records show AuroMedics Pharma LLC has 22 other recalls on record since Dec. 4, 2017. Other recent recalls include a Fondaparinux Injection recall for subpotent drug risk (Sept. 30, 2022), a Tranexamic Acid Injection recall for metal particulate hazard (Sept. 26, 2022), and an Acyclovir Injection recall for particulate matter hazard (Sept. 26, 2022). Other recent recalls of similar products include Par Health Buprenorphine Injections due to crystallization (Sept. 8, 2026) and Endo USA Buprenorphine Injection recall for crystallization risk (March 13, 2026).

How to tell if you have this one

Check for vials labeled 'Amiodarone Hydrochloride Injection, USP, 150 mg per 3 mL (50 mg / mL), 3 mL Single Dose Vial'. Look for NDC 55150-180-03 and Lot# CAH180009, expiring February 2020.

Brand
AuroMedics
Category
Drug

FDA recall event · 3 products

All 3 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class III
Status
Terminated
Distribution
Distributed Nationwide in the US
NDC
55150-180-03, 55150-181-09, 55150-182-18

Recall number	Product, codes & lots	Quantity
D-0520-2020	Amiodarone Hydrochloride Injection, USP, 150 mg per 3 mL (50 mg / mL), 3 mL Single Dose Vial, Rx only, Distributed by AuroMedics Pharma LLC E. Windsor, NJ. 08520, Made in India. NDC 55150-180-03; Lot# CAH180009, exp. date Feb 2020	28,810 vials
D-0521-2020	Amiodarone Hydrochloride Injection, USP, 450 mg per 9 mL (50 mg / mL), 9 mL Single Dose Vial, Rx only, Distributed by AuroMedics Pharma LLC E. Windsor, NJ. 08520, Made in India. NDC 55150-181-09; Lot# CAH180001, exp. date Jan 2020; CAH180003, exp. date Feb 2020; CAH180011, CAH180012, exp. date Jun 2020	29,830 vials
D-0522-2020	Amiodarone Hydrochloride Injection, USP, 900 mg per 18 mL (50 mg / mL), 18 mL Multiple Dose Vial, Rx only, Distributed by AuroMedics Pharma LLC E. Windsor, NJ. 08520, Made in India. NDC 55150-182-18; Lot#: CAH180013, CAH180014, exp. date Jul 2020	138,720 vials

Based on the official FDA remedy

What to do — step by step

Check Vial Details
Identify the NDC code 55150-180-03 and lot number CAH180009 on the vial label.

Where it went and when

Where it was distributed

Distributed nationwide.

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

Distributed nationwide.

Recall timeline

FDA terminated this recall 17 months after the firm started it.

Nov 11, 2019Firm started the recall
Nov 22, 2019FDA classified it Class III
Dec 4, 2019Published in FDA’s Enforcement Report
Apr 1, 2021FDA 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/37739-auromedics-amiodarone-injection-recall-crystallization-risk">AuroMedics Amiodarone Injection Recall: Crystallization Risk (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-0520-2020 (November 11, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0520-2020 to see it in context.
Plain-language summary written by qwen3:4b on October 5, 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.