Stop using now Drug recall · FDA · Published March 31, 2025

Leiters Health Rocuronium Syringes Recall: Risk of Contaminated Syringes

Leiters Health recalls Rocuronium Bromide 50mg/5mL syringes due to leaking/damaged syringes that could cause contamination. Affected units have NDC 71449-004-11 and lot 2530023.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-0374-2025Drug Leiters Health ›

Stop using this now

Lack of Assurance of Sterility: Leaking/damaged syringes.

Take action

Contact the company

Recalling firmDenver Solutions, LLC DBA Leiters Health13796 Compark Blvd · Englewood, CO 80112-7145

✎ GovInfoNow plain-language explainer

Leiters Health is recalling Rocuronium Bromide 50 mg per 5mL single-dose syringes because they may leak or become damaged, risking contamination. This is a serious issue for medical use since contaminated syringes could cause infections or other health problems. Read more at govinfonow.com/recall/32163-leiters-health-rocuronium-syringes-recall-risk-of-contaminated-syringes.

Source Summary by GovInfoNow · govinfonow.com/recall/32163-leiters-health-rocuronium-syringes-recall-risk-of-contaminated-syringes · Updated August 18, 2026 · FDA enforcement record: FDA #D-0374-2025

Cite this page

“Leiters Health Rocuronium Syringes Recall: Risk of Contaminated Syringes.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/32163-leiters-health-rocuronium-syringes-recall-risk-of-contaminated-syringes. Based on FDA recall #D-0374-2025 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0374-2025%22&limit=1).

The FDA announced on March 31, 2025, that Denver Solutions, LLC DBA Leiters Health is recalling Rocuronium Bromide syringes due to a lack of assurance of sterility caused by leaking or damaged syringes. Owners should contact the company for details.

How to tell if you have it

Brand: Leiters Health
Product: Rocuronium Bromide 50 mg per 5mL (10mg per mL), 5mL Single Dose Syringe, Rx only
NDC: 71449-004-11
Lot #: 2530023
Expiration Date: 7/12/2025
Quantity: 16,655 syringes
Distribution: Nationwide in the U.S.A

The hazard

The recall addresses a lack of assurance of sterility resulting from leaking or damaged syringes. The FDA classified this as a Class II recall.

Context

GovInfoNow's records show Denver Solutions, LLC DBA Leiters Health has five other recalls on record since November 29, 2021. Other recent recalls of similar products include Cipla Lanreotide Injection Recall: Risk of Contamination Due to Sterility Issues (March 13, 2026), B. Braun Medical Lactated Ringer's Injection Recall: Particulate Matter Hazard (April 28, 2026), and Cipla Lanreotide Injection Recall: Particulate Matter Hazard (January 2, 2026).

How to tell if you have this one

Check for the NDC number 71449-004-11 and lot number 2530023 on the syringe packaging. These syringes were sold with the expiration date of July 12, 2025.

Brand
Leiters Health
Category
Drug

FDA recall event · 5 products

All 5 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 U.S.A

Recall number	Product, codes & lots	Quantity
D-0370-2025	Glycopyrrolate, 1mg per 5mL, (0.2 mg/mL), Single Dose 5 mL syringe, Rx only, Leiters Health, 13796 Compark Blvd, Englewood, CO 80112. NDC 71449-104-11; Lot #: 2431015B, Exp. 4/10/2025.	170 syringes
D-0371-2025	dexmedeTOMIDine HCl PF, in 0.9% Sodium Chloride, 20 mcg (base) per 5mL, (4 mcg (base) per mL), 5mL Single Dose syringe, Rx only, Leiters Health, 13796 Compark Blvd, Englewood, CO 80112, NDC: 71449-131-11.; Lot #: 2431276A, Exp.: 4/20/2025	23,610 syringes
D-0372-2025	PHENYLephrine HCl in 0.9% Sodium Chloride, 0.5 mg per 5mL (100 mcg/mL), 5 mL Single Dose Syringe, Rx Only, Leiters Health, 13796 Compark Blvd, Englewood, CO 80112. NDC: 71449-001-11,; Lot #: 2431349A, Exp.: 6/16/2025	7,290 syringes
D-0373-2025	Ketamine HCl 50mg per 5mL (10 mg per mL), 5mL Single Dose Syringe, Rx only, Leiters Health, 13796 Compark Blvd, Englewood, CO 80112.NDC: 71449-068-11; Lot #:2530019, Exp.: 7/10/2025; 2530053, Exp.: 7/19/2025.	49,830 syringes
D-0374-2025	Rocuronium Bromide 50 mg per 5mL (10mg per mL), 5mL Single Dose Syringe, Rx only, Leiters Health, 13796 Compark Blvd, Englewood, CO 80112. NDC: 71449-004-11; Lot #:2530023, Exp.: 7/12/2025	16,655 syringes

Based on the official FDA remedy

What to do — step by step

Stop Using It Now
Immediately stop using any Rocuronium Bromide 50 mg per 5mL syringes with NDC 71449-004-11 and lot 2530023.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “Nationwide in the U.S.A” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA published this recall 30 days after the firm started it.

Mar 31, 2025Firm started the recall
Apr 18, 2025FDA classified it Class II
Apr 30, 2025Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/32163-leiters-health-rocuronium-syringes-recall-risk-of-contaminated-syringes">Leiters Health Rocuronium Syringes Recall: Risk of Contaminated Syringes (GovInfoNow)</a>

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-0374-2025 (March 31, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0374-2025 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.