CLASS II ONGOING Drug recall · Reported 9 Sep 2026 · FDA Enforcement Report
Vancomycin Injection, USP in 5% Dextrose per (5 mg/mL) recalled
Baxter Healthcare is recalling Vancomycin Injection, USP in 5% Dextrose per (5 mg/mL), in Galaxy Single-Dose Container, distributed nationwide in the US. The recall was initiated on 6 Aug 2026 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-0805-2026
- FDA event ID
- 99500
- Recalling firm
- Baxter Healthcare, Deerfield, IL
- Manufacturer
- Baxter Healthcare Corporation
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 6 Aug 2026
- FDA classified
- 28 Aug 2026
- Reported
- 9 Sep 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Antibiotics
Timeline
| 6 Aug 2026 | Recall initiated by company | |
| 28 Aug 2026 | Classified by FDA | +22 days |
| 9 Sep 2026 | 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
CGMP Deviations
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Vancomycin Injection, USP in 5% Dextrose, 1 g per 200mL (5 mg/mL), in GALAXY Single-Dose Container, Rx only, Sterile Nonpyrogenic, Iso-osmotic, Baxter Healthcare Corporation, Deerfield, IL, 60015 USA, NDC 0338-3552-48.
Where it was distributed
US Nationwide; Puerto Rico; and Chile.
Questions about this recall
Is Vancomycin Injection, USP in 5% Dextrose per (5 mg/mL), in Galaxy Single-Dose Container recalled?
Yes. Baxter Healthcare recalled Vancomycin Injection, USP in 5% Dextrose per (5 mg/mL), in Galaxy Single-Dose Container on 6 Aug 2026. The recall is Class II and its status is Ongoing. Recall number D-0805-2026.
Why was it recalled?
CGMP Deviations
Which lots are affected?
Lot # NC188678, Exp Date: 12/1/2026; Lot # NC188814, Exp Date: 12/5/2026; Lot # NC188944, Exp Date: 12/8/2026; Lot # NC193610, Exp Date: 4/21/2027, Lot # NC193665, Exp Date: 4/23/2027.
Where was it sold?
US Nationwide; Puerto Rico; and Chile.
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.
More recalls from Baxter Healthcare
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|---|---|---|---|---|---|
| Device | CLASS II | Baxter Novum IQ Syringe Pump, Loaner recalled by Baxter Healthcare | Baxter Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Baxter Novum IQ Syringe Pump recalled by Baxter Healthcare | Baxter Healthcare | Device Malfunction | Nationwide |
| Drug | CLASS II | Clindamycin Phosphate in 9% Sodium Chloride Injection recalledClindamycin Phosphate | Baxter Healthcare | Sterility | Nationwide |
| Drug | CLASS II | Clindamycin Injection USP in 5% Dextrose, 900 mg recalledClindamycin Phosphate | Baxter Healthcare | Sterility | Nationwide |
| Drug | CLASS II | Vasopressin, in 9% Sodium Chloride Injection per/mL) recalledVasopressin In 0.9% Sodium Chloride | Baxter Healthcare | Sterility | Nationwide |
Other Vancomycin recalls
All 20| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| 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 |
| Drug | CLASS I | Firvanq (vancomycin hydrochloride for oral solution) recalledFirvanq | Azurity Pharmaceuticals | Packaging Defects | Nationwide |