CLASS II Drug recall · Reported 20 Jul 2016 · FDA Enforcement Report
Diazepam Injection USP 10mg/ (5 mg/mL recalled by Hospira
Hospira is recalling Diazepam Injection USP 10mg/ (5 mg/mL, distributed nationwide in the US. The recall was initiated on 23 Jun 2016 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-1359-2016
- FDA event ID
- 74399
- Recalling firm
- Hospira, Lake Forest, IL
- Brand
- Diazepam
- Manufacturer
- Hospira, Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 23 Jun 2016
- FDA classified
- 12 Jul 2016
- Reported
- 20 Jul 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Particulate Matter
- Drug class
- Anxiety & Sleep Medication
Timeline
| 23 Jun 2016 | Recall initiated by company | |
| 12 Jul 2016 | Classified by FDA | +19 days |
| 20 Jul 2016 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Crystallization: Product contains particulate identified to be crystallized active ingredient.
Product as listed by the FDA
Diazepam Injection USP 10mg/2mL (5 mg/mL, 2 mL), Rx only, Hospira Inc. Lake Forest, IL 60045, NDC 0409-1273-32
Where it was distributed
Nationwide
Questions about this recall
Is Diazepam Injection USP 10mg/ (5 mg/mL recalled?
Yes. Hospira recalled Diazepam Injection USP 10mg/ (5 mg/mL on 23 Jun 2016. The recall is Class II and its status is Terminated. Recall number D-1359-2016.
Why was it recalled?
Crystallization: Product contains particulate identified to be crystallized active ingredient.
Which lots are affected?
Lot #: 52610LL, Exp. 01 OCT 2016; Lot #: 57660LL, Exp. 01 MAR 2017
Where was it sold?
Nationwide
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 21 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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| Drug | CLASS II | Fentanyl Citrate Injection, USP, 100 mcg Fentanyl recalled by Hospira | Hospira | Sterility | Nationwide |
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Other Diazepam recalls
All 8| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Diazepam Oral Solution (Concentrate), 25 mg recalled by Lannett Company | Lannett Company | Potency & Assay | Nationwide |
| Drug | CLASS III | Diazepam Rectal Gel, 5 mg, Twin Pack that Contains recalledDiazepam | Valeant Pharmaceuticals North America | Other | Nationwide |
| Drug | CLASS II | Diazepam Injection, USP, 5 mg/mL recalled by HospiraDiazepam | Hospira | Sterility | Nationwide |
| Drug | CLASS II | Diazepam Injection, USP 5 mg/mL, Multiple-dose fliptop vial recalledDiazepam | Hospira | Sterility | Nationwide |
| Drug | CLASS II | Diazepam Injection, USP 5 mg/mL, Multiple-dose fliptop vial recalledDiazepam | Hospira | Sterility | Nationwide |