CLASS II Drug recall · Reported 14 Mar 2018 · FDA Enforcement Report
Labetalol Hydrochloride Injection, USP, 100 mg recalled
Hospira Inc. A Pfizer is recalling Labetalol Hydrochloride Injection, USP, 100 mg/ (5 mg/mL) Multidose Vial, distributed nationwide in the US. The recall was initiated on 20 Feb 2018 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-0576-2018
- FDA event ID
- 79238
- Recalling firm
- Hospira Inc. A Pfizer, Mcpherson, KS
- Manufacturer
- Hospira, Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 20 Feb 2018
- FDA classified
- 2 Mar 2018
- Reported
- 14 Mar 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Foreign Material
- Drug class
- Injectable & IV Drugs
Timeline
| 20 Feb 2018 | Recall initiated by company | |
| 2 Mar 2018 | Classified by FDA | +10 days |
| 14 Mar 2018 | 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
Defective Container: Cracked glass at the rim surface of glass vials, covered by the stopper and crimp seal.
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
Labetalol Hydrochloride Injection, USP, 100 mg/ 20 mL (5 mg/mL), 20 mL Multidose Vial, Rx only, labeled as a) Hospira, Inc., Lake Forest, IL 60045, NDC 0409-2267-20; and b) NOVAPLUS, Manufactured by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-2267-25.
Where it was distributed
Nationwide in the USA and Puerto Rico.
Questions about this recall
Why was it recalled?
Defective Container: Cracked glass at the rim surface of glass vials, covered by the stopper and crimp seal.
Which lots are affected?
Lots: a) 74370DD, Exp 1FEB2019; 75035DD, 75115DD, Exp 1MAR2019; b) 74230DD, Exp 1FEB2019
Where was it sold?
Nationwide in the USA 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 Inc. A Pfizer
All 9| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Argatroban Injection, 250 mg/ (100 mg/mL) Single-use vial recalled | Hospira Inc. A Pfizer | Potency & Assay | Nationwide |
| Drug | CLASS II | Levophed norepinephrine bitartrate, injection, USP, 4 mg / (1 mg/mL) recalledLevophed | Hospira Inc. A Pfizer | Packaging Defects | Nationwide |
| Drug | CLASS I | Vancomycin Hydrochloride for Injection, USP, Pharmacy recalled | Hospira Inc. A Pfizer | Particulate Matter | Nationwide |
| Drug | CLASS II | METRONIDazole Injection, USP 500 mg (5 mg/mL) recalled | Hospira Inc. A Pfizer | Sterility | Nationwide |
| Drug | CLASS I | Bupivacaine Hydrochloride Inj., USP (2.5 mg/mL) recalledBupivacaine Hydrochloride | Hospira Inc. A Pfizer | Particulate Matter | 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 |