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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

Leiters Health Syringes Recalled for Potential Sterility Loss

Agency Publication Date: April 18, 2025
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Summary

Denver Solutions, LLC, doing business as Leiters Health, is recalling 97,555 single-dose syringes of various injectable medications, including glycopyrrolate, dexmedetomidine, phenylephrine, ketamine, and rocuronium bromide. The recall was initiated because some syringes may be leaking or damaged, which prevents the medication from remaining sterile. Using a non-sterile injectable drug can lead to serious or life-threatening infections. These products were distributed to hospitals and clinics across the United States.

Risk

The sterile barrier of the syringes may be compromised due to leaks or damage, potentially allowing bacteria or other contaminants to enter the medication. If contaminated medication is injected into a patient, it could cause systemic infections or other severe medical complications.

What You Should Do

  1. This recall involves single-dose 5 mL syringes of Glycopyrrolate, Dexmedetomidine HCl, Phenylephrine HCl, Ketamine HCl, and Rocuronium Bromide produced by Leiters Health.
  2. Check the medication labels for the following lot numbers: Glycopyrrolate (lot 2431015B), Dexmedetomidine (lot 2431276A), Phenylephrine (lot 2431349A), Ketamine (lots 2530019 and 2530053), or Rocuronium Bromide (lot 2530023).
  3. Stop using the recalled product immediately.
  4. Contact Leiters Health or your pharmaceutical distributor to arrange for the return of any remaining inventory.
  5. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional information or to report any adverse events.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return.

Affected Products

Product: Glycopyrrolate (1mg per 5mL, 0.2 mg/mL)by Leiters Health
Variants: Single Dose 5 mL syringe, Rx only
Lot Numbers:
2431015B (Exp. 4/10/2025)
NDC:
71449-104-11

Quantity: 170 syringes

Product: dexmedeTOMIDine HCl PF in 0.9% Sodium Chloride (20 mcg base per 5mL, 4 mcg base per mL)by Leiters Health
Variants: 5mL Single Dose syringe, Rx only
Lot Numbers:
2431276A (Exp.: 4/20/2025)
NDC:
71449-131-11

Quantity: 23,610 syringes

Product: PHENYLephrine HCl in 0.9% Sodium Chloride (0.5 mg per 5mL, 100 mcg/mL)by Leiters Health
Variants: 5 mL Single Dose Syringe, Rx Only
Lot Numbers:
2431349A (Exp.: 6/16/2025)
NDC:
71449-001-11

Quantity: 7,290 syringes

Product: Ketamine HCl (50mg per 5mL, 10 mg per mL)by Leiters Health
Variants: 5mL Single Dose Syringe, Rx only
Lot Numbers:
2530019 (Exp.: 7/10/2025)
2530053 (Exp.: 7/19/2025)
NDC:
71449-068-11

Quantity: 49,830 syringes

Product: Rocuronium Bromide (50 mg per 5mL, 10mg per mL)by Leiters Health
Variants: 5mL Single Dose Syringe, Rx only
Lot Numbers:
2530023 (Exp.: 7/12/2025)
NDC:
71449-004-11

Quantity: 16,655 syringes

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 96607
Status: Active
Manufacturer: Denver Solutions, LLC DBA Leiters Health
Sold By: Wholesalers; Hospitals; Clinics
Manufactured In: United States
Units Affected: 5 products (170 syringes; 23,610 syringes; 7,290 syringes; 49,830 syringes; 16,655 syringes)
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.