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Stop using now Drug recall · FDA · Published June 23, 2016

Hospira Recalls Diazepam Injection Due to Crystallization Hazard

Hospira Inc. recalls specific lots of Diazepam Injection USP due to crystallized active ingredient particulates. Check lot numbers and expiration dates immediately.

🇺🇸 FDA recall #D-1359-2016DrugHospira ›
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Recalling firmHospira Inc.275 N Field Dr · Lake Forest, IL 60045-2579
✎ GovInfoNow plain-language explainer

What happened, in plain English

Hospira Inc. is recalling specific lots of Diazepam Injection USP 10mg/2mL because the product contains particulate matter identified as crystallized active ingredient. This defect affects 373,850 tubes distributed nationwide. The recall was initiated on June 23, 2016. Read more at govinfonow.com/recall/42576-hospira-recalls-diazepam-injection-due-to-crystallization-hazard.

Source Summary by GovInfoNow · govinfonow.com/recall/42576-hospira-recalls-diazepam-injection-due-to-crystallization-hazard · Updated October 9, 2026 · FDA enforcement record: FDA #D-1359-2016

Cite this page

“Hospira Recalls Diazepam Injection Due to Crystallization Hazard.” GovInfoNow, updated October 9, 2026. https://govinfonow.com/recall/42576-hospira-recalls-diazepam-injection-due-to-crystallization-hazard. Based on FDA recall #D-1359-2016 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1359-2016%22&limit=1).

Why it’s dangerous

The presence of crystallized active ingredient particulates means the drug's purity and dosage accuracy may be compromised. Injecting particulate matter can pose serious health risks to the patient, although specific injury details are not provided in this record.

Who’s affected

Patients and healthcare providers who possess or administer the recalled Diazepam Injection USP from the specific lots listed in the record. Individuals with these products are at risk of receiving a compromised medication.

How to tell if you have this one

Check for Diazepam Injection USP 10mg/2mL (5 mg/mL, 2 mL) with NDC 0409-1273-32. Verify if the lot number is 52610LL (Exp. 01 OCT 2016) or 57660LL (Exp. 01 MAR 2017).

  • Brand
    Hospira
  • Category
    Drug
Based on the official FDA remedy

What to do — step by step

  1. Stop Using Recalled Lots

    Do not use any Diazepam Injection from the affected lots due to the risk of crystallized particulates.

  2. Contact Healthcare Provider

    Consult your doctor or pharmacist for guidance on replacing the medication if you have one of the recalled lots.

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

Distributed nationwide.

Recall timeline

FDA terminated this recall 2.2 years after the firm started it.

1. Firm started the recall: Jun 23, 201612. FDA classified it Class II: Jul 12, 201623. Published in FDA’s Enforcement Report: Jul 20, 201634. FDA terminated the recall: Aug 31, 2018420162018
  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.

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Questions people ask

How many units of this product are being recalled?

A total of 373,850 tubes are included in this recall.

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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-1359-2016 (June 23, 2016) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1359-2016 to see it in context.
  • Plain-language summary written by qwen3.6:35b-a3b on October 9, 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