CLASS II Drug recall · Reported 4 Sep 2013 · FDA Enforcement Report
Diazepam Injection, USP, 5 mg/mL recalled by Hospira
Hospira is recalling Diazepam Injection, USP, 5 mg/mL, Multiple-dose Sterile Non-pyrogenic, Fliptop Vial, C-IV, distributed nationwide in the US. The recall was initiated on 16 Aug 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-927-2013
- FDA event ID
- 66104
- Recalling firm
- Hospira, Lake Forest, IL
- Brand
- Diazepam
- Manufacturer
- Hospira, Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 16 Aug 2013
- FDA classified
- 28 Aug 2013
- Reported
- 4 Sep 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Anxiety & Sleep Medication
Timeline
| 16 Aug 2013 | Recall initiated by company | |
| 28 Aug 2013 | Classified by FDA | +12 days |
| 4 Sep 2013 | Published in enforcement report | +7 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: ineffective crimp on fliptop vials that may result in leaking at the neck of the vials.
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 Sterile Non-pyrogenic, Fliptop Vial, C-IV, 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: ineffective crimp on fliptop vials that may result in leaking at the neck of the vials.
Which lots are affected?
Lot: 23-505-EV, Exp. 11/14
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.
More recalls from Hospira
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|---|---|---|---|---|---|
| Drug | CLASS I | Infant 25% Dextrose Injection recalled by HospiraDextrose | Hospira | Particulate Matter | Nationwide |
| Device | CLASS II | Minibore Extension Set with Spin Lock Collar, Non-DEHP, Latex-Free recalled | Hospira | Other | Nationwide |
| Drug | CLASS III | 5% Lidocaine HCL and 7.5% Dextrose Injection, USP Single-dose ampule recalled | Hospira | Potency & Assay | PR |
| Drug | CLASS II | Fentanyl Citrate Injection, USP, 100 mcg Fentanyl recalled by Hospira | Hospira | Sterility | Nationwide |
| Device | CLASS II | LifeCare PCA 3, PCA recalled by Hospira | Hospira | Device Malfunction | Nationwide |
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 Injectable, compounded by Pallimed Solutions recalled | Pallimed Solutions | Sterility | Nationwide |