Last checked against FDA data: September 28, 2026.
Short answer: the FDA's weekly Enforcement Reports list 20 Baxter drug recalls reported between August 19 and September 16, 2026. Three are Class I, the FDA's most serious category: particulate matter in cefazolin bags, fiberglass in 0.9% sodium chloride (saline) bags, and stainless-steel particles in 70% dextrose. The other 17 are Class II recalls of premixed IV drugs, all listed on September 9 with the same reason: "CGMP deviations." Most news coverage focused on the fiberglass and steel recalls. The full list is below.
The three Class I recalls
| Recall no. | Product | Problem | Quantity (per FDA record) | Reported by FDA |
|---|---|---|---|---|
| D-0787-2026 | Cefazolin in Dextrose, 2 g / 100 mL, GALAXY frozen premix bag | Particulate matter | 19,032 bags | Aug 19 |
| D-0849-2026 | 0.9% Sodium Chloride Injection, 500 mL VIAFLEX bag | Particulates identified as fiberglass | 145,464 bags | Sep 9 |
| D-0850-2026 | Dextrose Injection 70%, 2,000 mL pharmacy bulk bag | Particulates identified as stainless steel | 606 bags | Sep 16 |
The saline recall is the one most people have heard about. Baxter's own announcement, posted by the FDA on August 26, covers two lots (Y495523 and Y495523A, expiring October 31, 2027) shipped July 31 to August 3 to 14 states: Florida, Illinois, Indiana, Louisiana, Maryland, Missouri, North Carolina, New Jersey, Nevada, New York, Ohio, South Carolina, Texas and Virginia. It warns that fiberglass particles could block blood vessels and cause clots, including a pulmonary embolism. Baxter said it had received no reports of adverse events. Local reporting traced the saline and a related anticoagulant recall to Baxter's North Cove plant in Marion, North Carolina. That anticoagulant recall (sodium citrate, one lot, one customer) doesn't appear in the drug Enforcement Report.
The 17 Class II recalls reported on September 9
All 17 were started by Baxter on August 6, list "CGMP deviations" as the reason, and were distributed across the US, Puerto Rico and Chile. They are ready-to-use IV drugs in premixed bags, several of them antibiotics used in hospitals every day:
| Drug (premixed bag) | Recall numbers |
|---|---|
| Clindamycin (in 5% dextrose or 0.9% sodium chloride; 600 mg and 900 mg strengths) | D-0808, D-0815, D-0816, D-0817, D-0818 |
| Vancomycin 1 g (in 5% dextrose or 0.9% sodium chloride) | D-0805, D-0820 |
| Daptomycin (500 mg and 1,000 mg) | D-0807, D-0821 |
| Vasopressin (20 and 40 units) | D-0811, D-0819 |
| Myxredlin (insulin human, 100 units / 100 mL) | D-0806 |
| Famotidine 20 mg | D-0809 |
| Dexmedetomidine | D-0810 |
| Pantoprazole 80 mg | D-0812 |
| Cardene IV (nicardipine) | D-0813 |
| Nexterone (amiodarone) | D-0814 |
"CGMP" means Current Good Manufacturing Practice, the FDA's rules for how drugs must be made, tested and controlled. A CGMP recall says the process didn't meet those rules. It doesn't necessarily mean anything was found in the product. The public record doesn't say which step failed for these 17. The full lot numbers for each are in the FDA record, linked below.
What the recall classes mean
- Class I: a reasonable chance the product could cause serious health problems or death.
- Class II: the product could cause temporary or medically reversible problems, or serious harm is unlikely.
- Class III: the product is unlikely to cause harm but breaks FDA rules, for example a labeling error.
Patients shouldn't act on this list alone. If you're receiving IV therapy and are worried, ask your care team or pharmacist; they have the lot numbers. Hospitals and pharmacies get recall notices directly from Baxter and their distributors.
How to check FDA drug recalls yourself (free)
- FDA Enforcement Report. Every recall the FDA classifies is published weekly, usually on Wednesdays. You can search it by firm, product or date.
- FDA's Recalls page. It lists company announcements. Many recalls, especially Class II, never get one and appear only in the Enforcement Report.
- openFDA. The same Enforcement Report data is available through a free public API. For example, this query returns Baxter's drug recalls reported in August and September 2026:
https://api.fda.gov/drug/enforcement.json?search=recalling_firm:"Baxter"+AND+report_date:[20260801+TO+20260930]&limit=50
The catch is keeping up. A recall is listed once, then changes quietly: a lot gets added, a classification is assigned, the status moves from ongoing to terminated. Catching those changes means re-checking and comparing by hand every week.
Tracking recalls automatically
We built US FDA Recalls Scraper for exactly that. It's part of NexGenWatch, our store of change feeds from official sources. A first run returns the current recalls across drugs, devices and food. After that, watch mode returns only what changed: new recalls, new classifications, status changes. Choose drugs, devices or food, and filter by classification. It lists at \$0.05 per recall change found, plus \$0.10 per check and a \$0.02 start fee per run, so a quiet week costs cents. Results come as JSON, CSV or Excel, or through the Apify API.
Sources
- openFDA drug enforcement records, Baxter, Aug–Sep 2026
- FDA: Baxter voluntary recall of two lots of 0.9% Sodium Chloride Injection (Aug 26, 2026)
- WLOS: recalls traced to Baxter's North Cove facility
- FDA Enforcement Report search
- FDA: recall background and class definitions
This summarizes public FDA records and news reports. It isn't medical advice. Counts reflect the FDA's drug Enforcement Report as of September 28, 2026 and may change as the FDA updates its records.
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