CLASS II Drug recall · Reported 16 Jul 2014 · FDA Enforcement Report
Labetalol Hydrochloride Injection, USP, 100 mg recalled by Hospira
Hospira is recalling Labetalol Hydrochloride Injection, USP, 100 mg/ (5 mg/mL) Multidose Vial, packaged glass, distributed nationwide in the US. The recall was initiated on 16 May 2014 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-1424-2014
- FDA event ID
- 68296
- Recalling firm
- Hospira, Lake Forest, IL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 16 May 2014
- FDA classified
- 8 Jul 2014
- Reported
- 16 Jul 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Press Release
- Reason category
- Particulate Matter
- Drug class
- Injectable & IV Drugs
Timeline
| 16 May 2014 | Recall initiated by company | |
| 8 Jul 2014 | Classified by FDA | +53 days |
| 16 Jul 2014 | 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
Presence of Particulate Matter; metal embedded in the glass vial and visible particles floating in the solution
Product as listed by the FDA
Labetalol Hydrochloride Injection, USP, 100 mg/20 mL (5 mg/mL), 20 mL Multidose Vial, packaged 50/20 mL glass vials/carton, Hospira, Inc., Lake Forest, IL 60045 --- NDC 0409-2267-20
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Presence of Particulate Matter; metal embedded in the glass vial and visible particles floating in the solution
Which lots are affected?
Lot 36225DD, exp 12/01/2015
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 4 Oct 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 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 Labetalol recalls
All 16| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Labetalol Hydrochloride Injection, USP, 20 mg recalled by PfizerLabetalol Hydrochloride | Pfizer | Sterility | Nationwide |
| Drug | CLASS II | labetalol HCl 20 mg/ Injection, (Concentration=5 mg/mL) fill Syringe recalled | SCA Pharmaceuticals | Sterility | Nationwide |
| Drug | CLASS II | Labetalol HCl Injection, USP, 20 mg/ (5 mg/mL) syringe recalled | Nephron Sterile Compounding Center | Sterility | Nationwide |
| Drug | CLASS II | Labetalol Hydrochloride Tablets, USP, 100 mg recalled | Mckesson Medical-Surgical Inc. Corporate Office | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Labetalol HCl Injection, USP, 20 mg/ (5 mg/mL) recalled | Nephron Sterile Compounding Center | Sterility | Nationwide |