Hospira Recalls Vancomycin Hydrochloride Vials Due to Mislabeling
Hospira Inc. is recalling 316,640 vials of Vancomycin Hydrochloride for Injection because product trays were mislabeled to contain a different product.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences, and the issue is a packaging/labeling error rather than a contamination or defect in the drug itself.
Plain-English summary
Hospira Inc. is recalling 316,640 vials of Vancomycin Hydrochloride for Injection, USP. The affected product is sterile powder in 25 ml fliptop vials, packaged in 10-count trays, and is available by prescription only. The recall covers specific lots with expiration dates of 07/16 and 08/16.
The recall was initiated because the product trays containing the vials were mislabeled to indicate they contained a different product. This is a Class III recall, which the FDA defines as a situation where use of, or exposure to, a violative product is not likely to cause adverse health consequences.
The affected product was distributed nationwide. Healthcare providers and patients should check their inventory for the specific lot numbers and expiration dates listed in the recall notice. If the product is found, it should be quarantined and not used until further notice.
The recalled product
- Product
- VANCOMYCIN HYDROCHLORIDE (VANCOMYCIN HYDROCHLORIDE)
- Brand
- VANCOMYCIN HYDROCHLORIDE
- Manufacturer
- Hospira Inc.
- Category
- Drug — Antibiotic
- Hazard
- Affected units
- 316,640
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 (6)
- Lot# 43-240-DD
- Exp. 07/16 Lot# 44-205-DD
- 44-455-DD
- 44-460-DD
- 44-465-DD
- Exp. 08/16
Distribution
Distributed nationwide across the United States.
Related recalls
Same brand · VANCOMYCIN HYDROCHLORIDE
- SevereBaxter Recalls Vancomycin Injection Due to CGMP Deviations
FDA (Drugs) · 2026-09-09
- HighBaxter Recalls Vancomycin Injection Due to Manufacturing Deviations
FDA (Drugs) · 2026-09-09
- SevereVancomycin Hydrochloride Oral Solution Recalled Nationwide for Superpotency Due to Overfilling
FDA (Drugs) · 2024-04-24
- CriticalVancomycin Hydrochloride Injection Recalled for Glass Particulate Matter
FDA (Drugs) · 2023-02-01
- ModerateAuroMedics Recalls Vancomycin Hydrochloride Vials Due to Discoloration
FDA (Drugs) · 2019-12-18
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 · mis labeling
See all →- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-10-14
- SevereBetter Bakehouse Recalls Donutful Chocolate Dipped Vanilla Cake Donuts for Undeclared Milk
FDA (Food) · 2026-10-14
- HighFreshPoint Recalls Cranberry Chicken Salad Wedges for Undeclared Egg Allergen
FDA (Food) · 2026-10-14
- HighJ K Patisserie & Bakery LLC Recalls Croissants for Undeclared Egg
FDA (Food) · 2026-10-14
- LowMindray ePM Series Patient Monitor Manuals Recalled for Alarm Clarification
FDA (Devices) · 2026-10-14
Similar recalls
- ModerateHospira Recalls Vancomycin Hydrochloride Injection Due to Temperature Abuse
FDA (Drugs) · 2015-02-25
- SevereHospira Recalls Vancomycin Hydrochloride Injection Due to Particulate Matter
FDA (Drugs) · 2017-04-12
- ModerateHospira Recalls Vancomycin Hydrochloride Injection Due to Temperature Excursions
FDA (Drugs) · 2015-02-25
- CriticalPfizer Recalls Vancomycin Hydrochloride Vials Due to Glass Particulate Matter
FDA (Drugs) · 2017-12-27
- SevereHospira Recalls Vancomycin Hydrochloride Injection Due to Cardboard Particulate Matter
FDA (Drugs) · 2016-06-22
- HighHospira Recalls Hydromorphone Hydrochloride Injection Due to Broken Vials
FDA (Drugs) · 2014-10-29