Leiters Health Moxifloxacin Vials Recall: Glass Particulate Risk
Leiters Health recalls specific moxifloxacin vials due to glass delamination causing particulate matter. Affected vials have lot numbers 2331123 (expiring Feb 2024) and 2331298 (expiring Mar 2024).
Lower-risk recall
Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delamination.
Contact the company
What happened, in plain English
Leiters Health is recalling certain moxifloxacin 5mg/ml vials because glass delamination in the vials may cause particulate matter. This could lead to contamination if the medication is administered. Read more at govinfonow.com/recall/32804-leiters-health-moxifloxacin-vials-recall-glass-particulate-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/32804-leiters-health-moxifloxacin-vials-recall-glass-particulate-risk · Updated August 10, 2026 · FDA enforcement record: FDA #D-0362-2024
Cite this page
“Leiters Health Moxifloxacin Vials Recall: Glass Particulate Risk.” GovInfoNow, updated August 10, 2026. https://govinfonow.com/recall/32804-leiters-health-moxifloxacin-vials-recall-glass-particulate-risk. Based on FDA recall #D-0362-2024 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0362-2024%22&limit=1).
Why it’s dangerous
Glass delamination in the vials can create small particles that may contaminate the medication. If these particles enter the bloodstream during injection, they could cause adverse reactions or infections.
Who’s affected
Prescription patients who received the recalled vials with lot numbers 2331123 (expiring Feb 2024) or 2331298 (expiring Mar 2024) are affected. Healthcare providers using these vials for medication administration are at risk.
How to tell if you have this one
Check for vials labeled 'Moxifloxacin 5mg/ml, 1 ml in a Single-Dose Vial, Rx Only' with lot numbers 2331123 (expiring Feb 2024) or 2331298 (expiring Mar 2024).
- Brand
Leiters Health- Category
Drug
All 3 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
Ongoing- Distribution
Nationwide in the USA
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-0361-2024 | Moxifloxacin PF, 1mg/ml, in Sterile Balanced Salt Solution (BSS) Sterile injection, Intracameral Use Only, Single- Dose Vial, Leiters 13796 Compark Blvd, Englewood, CO 80112, NDC 71449-096-42; Lot #:2331147, Exp:6-Mar-24; 2331180, Exp: 21-Mar-24; 2331256, Exp: 2-Apr-24; 2331279, Exp: 3-Apr-24; 2331283, Exp: 7-Apr-24; 2331345, Exp: 20-Apr-24; 2331422, Exp: 27-Apr-24; 2331563, Exp: 29-May-24. | 40,090 vials |
| D-0362-2024 | Moxifloxacin 5mg/ml, 1 ml in a Single- Dose Vial, Rx Only, Leiters 13796 Compark Blvd, Englewood, CO 80112, NDC 71449-097-42; Lot #:2331123, Exp:28-Feb-24; 2331298, Exp: 24-Mar-24. | 10,020 vials |
| D-0363-2024 | Lidocaine HCL 1% (10mg/mL), PHENYLephrine HCL 1.5% (15mg/mL), 1 ml in a Single- Dose Vial, RX Only, Leiters 13796 Compark Blvd, Englewood, CO 80112, NDC 71449-090-42; Lot #:2331104, Exp:9-Mar-24; 2331137, Exp: 3-Mar-24; 2331196, Exp: 11-Mar-24; 2331264, Exp: 6-Apr-24; 2331282, Exp: 18-Apr-24; 2331464, Exp: 8-May-24; 2331481, Exp: 16-May-24; 2331500, Exp: 20-May-24. | 40,890 vials |
What to do — step by step
Check Vial Lot Number
Identify the lot number on the vial label to determine if it is affected (2331123 or 2331298).
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide in the USA” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 15 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
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-0362-2024 (February 20, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0362-2024 to see it in context.
- Plain-language summary written by qwen3:4b on August 10, 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.