Lower riskDrug recall · FDA · Published November 29, 2021
Leiters Health Moxifloxacin Vials May Contain Wrong Dose - Recall
Leiters Health recalls 10 vials of moxifloxacin 1 mg/mL solution for intracameral injection due to potential label mix-up with 5 mg/mL concentration. This affects prescription-only products sold in the US.
“Leiters Health Moxifloxacin Vials May Contain Wrong Dose - Recall.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/35505-leiters-health-moxifloxacin-vials-may-contain-wrong-dose-recall. Based on FDA recall #D-0288-2022 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0288-2022%22&limit=1).
The FDA announced on November 29, 2021, that Denver Solutions, LLC DBA Leiters Health recalled Moxifloxacin vials due to a labeling mix-up where 1 mg/mL vials may contain 5 mg/mL. Owners should contact the company at (800) 292-6772 for details.
How to tell if you have it
Brand: Leiters Health
Product: Moxifloxacin, 1 mg/mL, 1mL in 2mL vial, solution for intracameral injection, 10 vials/carton, Rx only
NDC: 71449-096-42
Lot #: 2130958
Expiration Date: 03/31/2022
The hazard
The vials labeled as moxifloxacin 1 mg/mL may actually contain moxifloxacin 5 mg/mL. The FDA classified this recall as Class II.
Context
GovInfoNow's records show Denver Solutions, LLC DBA Leiters Health has had five other recalls since February 21, 2023. Recent recalls include a March 31, 2025 Dexmedetomidine Syringe recall for leaking risk and a February 20, 2024 Moxifloxacin PF Vials recall for glass particulate risk. Other recent recalls of similar products include an April 16, 2026 American Regent Levocarnitine Injection recall for missing label hazard and a February 9, 2026 Meitheal Cetrorelix Acetate Injection Kit recall for missing or duplicated needles.
How to tell if you have this one
Check for Leiters Health product code 13796 on the vial. The product is a prescription-only solution for intracameral injection, sold in 10-vial cartons with NDC 71449-096-42.
Brand
Leiters Health
Category
Drug
Based on the official FDA remedy
What to do — step by step
Verify Vial Label
Check the vial label for the concentration (1 mg/mL or 5 mg/mL) before use.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “Nationwide within the United States” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 7 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The product is safe if you verify the concentration on the label before use. However, the labeling error means you should not assume the concentration is correct.
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-0288-2022 (November 29, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0288-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 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.