Use caution Drug recall · FDA · Published September 12, 2014

Mylan Amiodarone Injection Recall: Temperature Abuse Risk

McKesson recalls Mylan Amiodarone HCl Injection vials stored at wrong temps. Check lot #140502, exp 10/31/2015 for potential potency issues.

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

🇺🇸 FDA recall #D-0005-2015Drug Mylan ›

Use caution until it’s fixed

Temperature Abuse: One shipment was inadvertantly stored refrigerated rather than the labeled room temperature recommendation at McKesson Medical-Surgical Inc., one of the distributing wholesalers.

Take action

Contact the company

Recalling firmMckesson4345 Southpoint Blvd · Jacksonville, FL 32216-6166

✎ GovInfoNow plain-language explainer

McKesson is recalling one shipment of Amiodarone HCl Injection manufactured for Mylan because it was inadvertently stored in a refrigerator instead of at room temperature. This specific lot contains only 10 vials distributed to medical facilities and physicians in Washington, Oregon, and Montana. The record does not specify the exact health consequences of this temperature abuse. Read more at govinfonow.com/recall/45761-mckesson-recalls-amiodarone-hcl-injection-450-mg-9-ml-50.

Source Summary by GovInfoNow · govinfonow.com/recall/45761-mckesson-recalls-amiodarone-hcl-injection-450-mg-9-ml-50 · Updated October 12, 2026 · FDA enforcement record: FDA #D-0005-2015

Cite this page

“Mylan Amiodarone Injection Recall: Temperature Abuse Risk.” GovInfoNow, updated October 12, 2026. https://govinfonow.com/recall/45761-mckesson-recalls-amiodarone-hcl-injection-450-mg-9-ml-50. Based on FDA recall #D-0005-2015 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0005-2015%22&limit=1).

The FDA announced on Sept. 12, 2014, that McKesson recalled Amiodarone HCl Injection manufactured for Mylan due to temperature abuse hazards. The agency stated the recall was voluntary and initiated by the firm.

How to tell if you have it

Brand: Mylan
Product: Amiodarone HCl Injection, 450 mg/9 mL (50 mg per mL), 9 mL Single-Use Vial
NDC: 67457-153-09
Lot #140502
Expiration: 10/31/2015
Quantity: 10 vials

The hazard

One shipment was inadvertently stored refrigerated rather than at the labeled room temperature recommendation. This occurred at McKesson Medical-Surgical Inc., one of the distributing wholesalers.

Context

GovInfoNow's records show McKesson has had three other recalls since Jan. 17, 2025, including a June 10, 2026, Gemcitabine Injection recall for temperature storage risk and a Jan. 16, 2026, UDENYCA Injection recall for temperature abuse. Other recent recalls of similar products include the July 2, 2026, Mylan Mycophenolate Mofetil Injection recall for precipitate risk and the Aug. 17, 2026, Mylan Prasugrel Tablets recall for failed stability testing.

How to tell if you have this one

Look for Amiodarone HCl Injection, 450 mg/9 mL (50 mg per mL), in a 9 mL Single-Use Vial. The product is manufactured for Mylan Institutional, LLC, has NDC 67457-153-09, and Lot #140502 with an expiration date of 10/31/2015.

Brand
Mylan
Category
Drug

Based on the official FDA remedy

What to do — step by step

Identify the product
Check if you have Amiodarone HCl Injection, Lot #140502, Exp 10/31/2015, distributed by McKesson to WA, OR, or MT.
Contact provider
If you are a medical facility or physician who received this shipment, contact McKesson Medical-Surgical Inc. for further instructions as the remedy is not stated in the record.

Where it went and when

Where it was distributed

Distributed in 3 states.

FDA distribution: “McKesson Medical-Surgical Inc distributed to (6) physicians and/or medical facilities in WA, OR, and MT.” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Montana, Oregon, Washington.

Recall timeline

FDA terminated this recall 2.6 years after the firm started it.

Sep 12, 2014Firm started the recall
Oct 3, 2014FDA classified it Class II
Oct 15, 2014Published in FDA’s Enforcement Report
Apr 17, 2017FDA terminated the recall

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

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Keep exploring

Link to this recall

<a href="https://govinfonow.com/recall/45761-mckesson-recalls-amiodarone-hcl-injection-450-mg-9-ml-50">Mylan Amiodarone Injection Recall: Temperature Abuse 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-0005-2015 (September 12, 2014) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0005-2015 to see it in context.
Plain-language summary written by qwen3.6:35b-a3b on October 12, 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.