CLASS II Drug recall · Reported 22 Jun 2016 · FDA Enforcement Report
Vancomycin Hydrochloride for Injection, USP vial recalled by Hospira
Hospira is recalling Vancomycin Hydrochloride for Injection, USP vial, distributed nationwide in the US. The recall was initiated on 6 May 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-1033-2016
- FDA event ID
- 73992
- Recalling firm
- Hospira, Lake Forest, IL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 6 May 2016
- FDA classified
- 15 Jun 2016
- Reported
- 22 Jun 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Particulate Matter
- Drug class
- Antibiotics
Timeline
| 6 May 2016 | Recall initiated by company | |
| 15 Jun 2016 | Classified by FDA | +40 days |
| 22 Jun 2016 | 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
Presence of Particulate Matter: Cardboard
Product as listed by the FDA
Vancomycin Hydrochloride for Injection, USP, 10 g, 100 mL vial, Rx only, Hospira, Lake Forest, IL, NDC 0409-6510-01
Where it was distributed
Nationwide
Questions about this recall
Is Vancomycin Hydrochloride for Injection, USP vial recalled?
Yes. Hospira recalled Vancomycin Hydrochloride for Injection, USP vial on 6 May 2016. The recall is Class II and its status is Terminated. Recall number D-1033-2016.
Why was it recalled?
Presence of Particulate Matter: Cardboard
Which lots are affected?
Lot #:565003A, Exp.01 Aug 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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Other Vancomycin recalls
All 20| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Vancomycin Injection, USP in 5% Dextrose per (5 mg/mL) recalledVancomycin Hydrochloride | Baxter Healthcare | Sterility | Nationwide |
| Drug | CLASS II | Vancomycin Injection, USP, in 9% Sodium Chloride recalledVancomycin Hydrochloride | Baxter Healthcare | Sterility | Nationwide |
| Drug | CLASS I | Vancomycin Hydrochloride for Oral Solution, USP, 250 mg recalledVancomycin Hydrochloride | Amneal Pharmaceuticals of New York | Potency & Assay | Nationwide |
| Drug | CLASS I | Vancomycin Hydrochloride for Injection, USP, Sterile powder recalledVancomycin Hydrochloride | Pfizer | Particulate Matter | Nationwide |
| Drug | CLASS II | Vancomycin HCl Oral Solution (PF) 125mg recalled by Edge Pharma | Edge Pharma | Manufacturing (CGMP) Deviations | Nationwide |