Hospira Recalls Labetalol Hydrochloride Injection Due to Particulate Matter
Hospira Inc. is recalling Labetalol Hydrochloride Injection due to the presence of particulate matter, including metal embedded in glass vials and visible particles in the solution.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, and the presence of metal embedded in glass vials and visible particles in an intravenous solution represents a significant injury risk, meeting the criteria for a Severe rating.
Plain-English summary
Hospira Inc. is recalling Labetalol Hydrochloride Injection, USP, 100 mg/20 mL (5 mg/mL), 20 mL Multidose Vial. The recall involves 45,448 vials distributed nationwide. The specific lot affected is 36225DD, with an expiration date of 12/01/2015. The product is identified by NDC 0409-2267-20.
The recall was initiated because of the presence of particulate matter. Specifically, metal was found embedded in the glass vials, and visible particles were observed floating in the solution. This defect poses a risk to patients receiving the intravenous medication.
Healthcare providers and patients should stop using the affected lot of Labetalol Hydrochloride Injection. Consumers and medical facilities should check their inventory for Lot 36225DD and contact Hospira Inc. or their local FDA office for further instructions on how to return or dispose of the product.
The recalled product
- Product
- LABETALOL HYDROCHLORIDE (LABETALOL HYDROCHLORIDE)
- Brand
- LABETALOL HYDROCHLORIDE
- Manufacturer
- Hospira Inc.
- Category
- Drug — Injection
- Affected units
- 45,448
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot 36225DD
- exp 12/01/2015
Distribution
Distributed nationwide across the United States.
Related recalls
Same brand · LABETALOL HYDROCHLORIDE
- HighInjectable Labetalol Hydrochloride Recalled Due to Incomplete Crimp Seals
FDA (Drugs) · 2024-07-03
- ModerateHospira Recalls Labetalol Hydrochloride Injection Due to Cracked Glass Vials
FDA (Drugs) · 2018-03-14
Same manufacturer · Hospira Inc.
See all →- CriticalHospira Recalls Dextrose Injection Syringes Due to Human Hair Particulate
FDA (Drugs) · 2017-05-31
- ModerateHospira Recalls Minibore Extension Sets Due to Solvent Occlusion
FDA (Devices) · 2017-01-18
- LowHospira Recalls Lidocaine and Dextrose Injection for Stability Failures
FDA (Drugs) · 2016-12-14
- SevereHospira Recalls Fentanyl Citrate Injection Ampules Due to Broken Tips
FDA (Drugs) · 2016-11-30
- HighHospira Symbiq Infusion Pump Recalled for White Screen Shutdown
FDA (Devices) · 2016-11-16
Same hazard · particulate matter
See all →- ModerateIMAAVY Injection Recalled for Presence of Particulate Matter
FDA (Drugs) · 2026-10-14
- HighICU Medical Recalls IV Sets with Potential Drip Chamber Discoloration
FDA (Devices) · 2026-09-23
- HighICU Medical Recalls IV Sets with Potential Drip Chamber Discoloration
FDA (Devices) · 2026-09-23
- HighICU Medical Recalls Plum Administration Sets Due to Drip Chamber Discoloration
FDA (Devices) · 2026-09-23
- HighICU Medical Recalls IV Sets with Potential Drip Chamber Discoloration
FDA (Devices) · 2026-09-23
Similar recalls
- SevereHospira Recalls Lidocaine Hydrochloride Injection Due to Particulate Matter
FDA (Drugs) · 2012-12-26
- ModerateHospira Recalls Labetalol Hydrochloride Injection Due to Cracked Glass Vials
FDA (Drugs) · 2018-03-14
- SevereHospira Recalls Lidocaine Hydrochloride Vials Due to Particulate Matter
FDA (Drugs) · 2014-10-22
- CriticalHospira Recalls Bupivacaine Hydrochloride Injection Due to Particulate Matter
FDA (Drugs) · 2013-12-25
- HighHospira Recalls Bupivacaine Hydrochloride Vials Due to Particulate Matter
FDA (Drugs) · 2014-03-12
- SevereHospira Recalls Metoclopramide Injection Due to Glass Particulate Matter
FDA (Drugs) · 2013-11-27