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Use caution Drug recall · FDA · Published March 8, 2017

McKesson Recalls Hydralazine Injections Due to Temperature Abuse

McKesson recalls specific lots of Hydralazine Hydrochloride Injection because they were stored refrigerated instead of at room temperature.

🇺🇸 FDA recall #D-0668-2017DrugMcKesson Medical-Surgical ›
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Recalling firmMckesson Medical Surgical9954 Mayland Dr · Henrico, VA 23233-1464
✎ GovInfoNow plain-language explainer

What happened, in plain English

McKesson Medical-Surgical is recalling Hydralazine Hydrochloride Injection, USP, 20 mg/mL, in 1 mL single-dose vials. The recall was issued because certain lots were inadvertently stored in a refrigerator rather than at the labeled room temperature. This improper storage may affect the drug's stability and efficacy. Read more at govinfonow.com/recall/41821-mckesson-recalls-hydralazine-injections-due-to-temperature-abuse.

Source Summary by GovInfoNow · govinfonow.com/recall/41821-mckesson-recalls-hydralazine-injections-due-to-temperature-abuse · Updated October 11, 2026 · FDA enforcement record: FDA #D-0668-2017

Cite this page

“McKesson Recalls Hydralazine Injections Due to Temperature Abuse.” GovInfoNow, updated October 11, 2026. https://govinfonow.com/recall/41821-mckesson-recalls-hydralazine-injections-due-to-temperature-abuse. Based on FDA recall #D-0668-2017 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0668-2017%22&limit=1).

Why it’s dangerous

The product was stored at refrigerated temperatures instead of the recommended room temperature. While the record does not specify exact chemical degradation, improper storage conditions can compromise the integrity and effectiveness of pharmaceutical products like this injection.

Who’s affected

Patients who have been prescribed or received Hydralazine Hydrochloride Injection from the affected lots distributed nationwide by McKesson Medical-Surgical.

How to tell if you have this one

Check for Hydralazine Hydrochloride Injection, USP, 20 mg/mL, 1 mL Single Dose Vial, packaged in cartons of 25. Look for NDC 63323-614-01 and Lot numbers 6114311 or 6114717 with an expiration date of 05/18.

  • Brand
    McKesson Medical-Surgical
  • Category
    Drug
Based on the official FDA remedy

What to do — step by step

  1. Check Your Inventory

    Verify if you have vials with NDC 63323-614-01 and Lot numbers 6114311 or 6114717.

  2. Contact Your Provider

    If you have the recalled product, contact your healthcare provider or pharmacist for guidance on disposal or replacement.

Where it went and when

Where it was distributed

Distributed nationwide.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

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 7.4 years after the firm started it.

1. Firm started the recall: Mar 8, 201712. FDA classified it Class II: Apr 12, 201723. Published in FDA’s Enforcement Report: Apr 19, 201734. FDA terminated the recall: Aug 19, 2024420172024
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

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

✎ GovInfoNow

Questions people ask

What is the NDC number for the recalled product?

The National Drug Code (NDC) is 63323-614-01.

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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-0668-2017 (March 8, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0668-2017 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.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA