CLASS II Drug recall · Reported 12 Jun 2013 · FDA Enforcement Report
Diazepam Injection, USP 5 mg/mL, Multiple-dose fliptop vial recalled
Hospira is recalling Diazepam Injection, USP 5 mg/mL, Multiple-dose fliptop vial, distributed nationwide in the US. The recall was initiated on 16 May 2013 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-501-2013
- FDA event ID
- 65315
- Recalling firm
- Hospira, Lake Forest, IL
- Brand
- Diazepam
- Manufacturer
- Hospira, Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 16 May 2013
- FDA classified
- 31 May 2013
- Reported
- 12 Jun 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Anxiety & Sleep Medication
Timeline
| 16 May 2013 | Recall initiated by company | |
| 31 May 2013 | Classified by FDA | +15 days |
| 12 Jun 2013 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Diazepam Injection, USP 5 mg/mL, 10 mL, Multiple-dose fliptop vial, RX only, HOSPIRA, INC. LAKE FOREST, IL 60045 USA, NDC 0409-3213-12
Where it was distributed
Nationwide and Puerto Rico
Questions about this recall
Why was it recalled?
Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial.
Which lots are affected?
17-099-EV Exp 05/14
Where was it sold?
Nationwide and Puerto Rico
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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|---|---|---|---|---|---|
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| Drug | CLASS II | Fentanyl Citrate Injection, USP, 100 mcg Fentanyl recalled by Hospira | Hospira | Sterility | Nationwide |
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Other Diazepam recalls
All 11| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | diazePAM 5 MG/ML Injection Solution (C-iv) Syr per syringe recalled | RXQ Compounding | Sterility | Nationwide |
| Drug | CLASS III | Diazepam Rectal Gel, 2.5 mg recalled by Valeant Pharmaceuticals NorthDiazepam | Valeant Pharmaceuticals North America | Other | Nationwide |
| Drug | CLASS II | Diazepam Injection USP 10mg/ (5 mg/mL recalled by HospiraDiazepam | Hospira | Particulate Matter | Nationwide |
| Drug | CLASS II | Diazepam 5 mg/mL injectable recalled by Martin Avenue Pharmacy | Martin Avenue Pharmacy | Sterility | Nationwide |
| Drug | CLASS II | Diazepam Injection, USP, 5 mg/mL recalled by HospiraDiazepam | Hospira | Sterility | Nationwide |