Baxter Milrinone Lactate Injection Recall: Leaks Risk Sterility Issues
Baxter recalls Milrinone Lactate injection due to leaks causing sterility concerns. Affected lots from 2017 with specific NDC numbers. Patients should contact for details.
Lower-risk recall
Lack of assurance of sterility: customer complaints received for the presence of leaks.
Contact the company
What happened, in plain English
Baxter is recalling a specific type of Milrinone Lactate injection because customer reports of leaks have raised sterility concerns. This could lead to infections if the medication is used without proper sterility. Read more at govinfonow.com/recall/41623-baxter-milrinone-lactate-injection-recall-leaks-risk-sterility-issues.
Source Summary by GovInfoNow · govinfonow.com/recall/41623-baxter-milrinone-lactate-injection-recall-leaks-risk-sterility-issues · Updated October 8, 2026 · FDA enforcement record: FDA #D-0789-2017
Cite this page
“Baxter Milrinone Lactate Injection Recall: Leaks Risk Sterility Issues.” GovInfoNow, updated October 8, 2026. https://govinfonow.com/recall/41623-baxter-milrinone-lactate-injection-recall-leaks-risk-sterility-issues. Based on FDA recall #D-0789-2017 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0789-2017%22&limit=1).
Why it’s dangerous
Leakage in the injection container can compromise sterility, potentially leading to infections if the medication is used without proper cleaning or handling. This is a concern for medical use where sterility is critical.
Who’s affected
Healthcare providers and patients using this specific injection for medical treatment. Those with the recalled lot numbers are most at risk.
How to tell if you have this one
Check for the product name 'Milrinone Lactate in 5% Dextrose Injection, 20 mg/100 mL, 100 mL Single-Dose Intravia Container bag' with lot numbers P342485 (expiring 11/30/2017) or P344408 (expiring 12/31/2017).
- Brand
Baxter- Category
Drug
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
US and foreign countries: United Arab Emirates, Colombia, and Canada
| Recall number | Product, codes & lots | Quantity | NDC |
|---|---|---|---|
| D-0788-2017 | Fluconazole Injection, USP, 200 mg/100 mL (2mg/mL), 100 mL Single-Dose Intravia Container bag, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, Product Code 2J1446, NDC 0338-6046-48; Lot #: P344028/P344028A, Exp 12/31/17; P352377, Exp 8/31/18; P348136, Exp 4/30/18 | 113,590 bags | 0338-6046-48, 0338-6045-37 |
| D-0789-2017 | Milrinone Lactate in 5% Dextrose Injection, 20 mg/100 mL, 100 mL Single-Dose Intravia Container bag, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, NDC 0338-6010-48; Lot #: P342485, Exp 11/30/17; P344408, Exp 12/31/17 | 90,450 bags | 0338-6010-48, 0338-6011-37 |
What to do — step by step
Check Product Details
Identify the lot number and expiration date on the container to confirm if it's affected.
How this recall unfolded
Recall timeline
FDA terminated this recall 15 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0789-2017 (May 15, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0789-2017 to see it in context.
- Plain-language summary written by qwen3:4b on October 8, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.