Manufacturer

Denver Solutions, LLC DBA Leiters Health

22 recalls in our database name Denver Solutions, LLC DBA Leiters Health as the manufacturing or recalling firm.

What the numbers show

Total: 22
Critical: 3
Severe: 7
Most recent: 2025-04-30

Of the 22 recalls from Denver Solutions, LLC DBA Leiters Health we have scored against our rubric, 3 (14%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 7 (32%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–22 of 22

SevereFDA (Drugs)·D-0373-2025·2025-04-30
Ketamine HCl Syringes Recalled for Lack of Sterility Assurance
Denver Solutions, LLC is recalling Ketamine HCl 50mg per 5mL single-dose syringes nationwide due to leaking or damaged syringes that may lack sterility assurance. Two affected lots are identified with expiration dates in July 2025.
Product
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
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0371-2025·2025-04-30
Dexmedetomidine HCl Syringes Recalled for Potential Sterility Issue
Leiters Health is recalling dexmedetomidine HCl PF syringes nationwide due to leaking or damaged syringes that may not maintain sterility. Affected lot 2431276A has an expiration date of 4/20/2025.
Product
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.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0372-2025·2025-04-30
PHENYLephrine HCl Injection Syringes Recalled for Lack of Sterility
Denver Solutions, LLC DBA Leiters Health is recalling PHENYLephrine HCl 0.5 mg per 5mL single-dose syringes because some syringes may be leaking or damaged, which could compromise sterility assurance.
Product
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,
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0374-2025·2025-04-30
Rocuronium Bromide Syringes Recalled Due to Sterility Assurance Risk
Denver Solutions, LLC DBA Leiters Health is recalling Rocuronium Bromide 50 mg per 5mL syringes due to potential leaking or damage that may compromise sterility assurance.
Product
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
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0370-2025·2025-04-30
Glycopyrrolate 1mg/5mL Syringes Recalled for Sterility Risk
Denver Solutions, LLC (DBA Leiters Health) is recalling Glycopyrrolate 1mg/5mL single-dose syringes (Lot #2431015B, expiration 4/10/2025) distributed nationwide because some syringes were found to be leaking or damaged, which compromises sterility assurance.
Product
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
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0363-2024·2024-03-06
Lidocaine and Phenylephrine Injectable Vials Recalled for Glass Delamination
Denver Solutions is recalling Lidocaine-Phenylephrine injectable vials nationwide due to glass delamination in the vials. The defect could potentially introduce glass fragments into the medication.
Product
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
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0361-2024·2024-03-06
Moxifloxacin Ophthalmic Injection Solution Recalled for Glass Particle Contamination
Denver Solutions is recalling Moxifloxacin PF eye injection vials nationwide due to glass delamination in the vials. The affected product is used for eye surgery injections.
Product
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
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0362-2024·2024-03-06
Moxifloxacin single-dose vials recalled for glass delamination nationwide
Denver Solutions is recalling 10,020 vials of Moxifloxacin 5mg/ml nationwide due to glass delamination in the vial packaging. Affected lots: 2331123 (exp. 2/28/24) and 2331298 (exp. 3/24/24).
Product
Moxifloxacin 5mg/ml, 1 ml in a Single- Dose Vial, Rx Only, Leiters 13796 Compark Blvd, Englewood, CO 80112, NDC 71449-097-42
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Drugs)·D-0279-2024·2024-02-07
Phenylephrine IV Bags Recalled for Double-Dose Filling System Malfunction
Denver Solutions is recalling 29,016 Phenylephrine HCl IV bags distributed nationwide. A filling system malfunction can result in some bags receiving double doses of this potent injectable drug.
Product
PHENYLephrine HCl 20 mg per 250 mL 0.9% Sodium Chloride (80 mcg per mL), Item F3360, for IV use only; Leiters 13796 Compark Blvd Englewood, CO 80112; NDC 71449-148-94.
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Drugs)·D-0277-2024·2024-02-07
Fentanyl Citrate IV Bags Recalled Due to Double-Dose Filling System Malfunction
Denver Solutions recalled 8,976 IV bags of fentanyl citrate nationwide due to a malfunction in the semi-automated filling system that could deliver double the intended dose.
Product
FentaNYL citrate PF, 1000 mcg per 100 mL 0.9% Sodium Chloride (10 mcg per mL), Item F3355, for IV use only; Leiters 13796 Compark Blvd Englewood, CO 80112; NDC 71449-072-41.
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Drugs)·D-0282-2024·2024-02-07
FDA Recalls Vancomycin IV Bags Due to Dosing System Malfunction
Denver Solutions is recalling 7,548 IV bags of vancomycin due to a manufacturing system malfunction that can deliver double doses. The product was distributed nationwide.
Product
VANCOmycin HCl PF 1.5g added to 0.9% Sodium Chloride 250 mL IV bag, Item F3208, for IV use only; Leiters 13796 Compark Blvd Englewood, CO 80112; NDC 71449-029-68.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0278-2024·2024-02-07
FentaNYL Citrate IV Bags Recalled Due to Double-Dose Filling System Malfunction
FentaNYL citrate intravenous bags are recalled nationwide because a semi-automated filling system can malfunction and deliver double the intended dose. Patients and healthcare providers should immediately quarantine affected lots.
Product
FentaNYL citrate PF, 2500 mcg per 250 mL 0.9% Sodium Chloride (10 mcg per mL), Item F3342, for IV use only; Leiters 13796 Compark Blvd Englewood, CO 80112; NDC 71449-072-82.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0281-2024·2024-02-07
Vancomycin IV bags recalled due to filling system malfunction causing double doses
Denver Solutions is recalling 10,152 Vancomycin IV bags nationwide because a filling system malfunction can deliver double doses of the antibiotic medication.
Product
VANCOmycin HCl PF 1.25g added to 0.9% Sodium Chloride 250 mL IV bag, Item F3206, for IV use only; Leiters 13796 Compark Blvd Englewood, CO 80112; NDC 71449-028-68.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0280-2024·2024-02-07
IV Phenylephrine Bags Recalled Due to Potential Double-Dose Delivery System Malfunction
Denver Solutions is recalling 12,564 bags of PHENYLephrine HCl IV solution nationwide due to a semi-automated filling system malfunction that could dispense double doses to patients.
Product
PHENYLephrine HCl 40 mg per 250 mL 0.9% Sodium Chloride (160 mcg per mL), Item F3352, for IV use only; Leiters 13796 Compark Blvd Englewood, CO 80112; NDC 71449-150-82.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0071-2024·2023-11-01
Vancomycin HCI IV bags recalled for labeling issue
Denver Solutions is recalling 33,480 Vancomycin HCI IV bags (NDC 71449-028-68) due to a labeling issue. The affected lots were distributed nationwide.
Product
VANCOmycin HCI PF, 1.25 g added to 0.9% Sodium Chloride 250 mL IV Bag, Rx only, Leiters Compounding Health, 13796 Compark Blvd, Englewood, CO 80112, NDC 71449-028-68.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0070-2024·2023-11-01
Oxytocin IV Bags Recalled Due to Labeling Defect
Denver Solutions recalls 6,276 IV bags of oxytocin due to a labeling defect. The product was distributed nationwide to healthcare facilities.
Product
Oxytocin synthetic, 30 Units added to 0.9% Sodium Chloride 500mL IV Bag (0.06 Units per mL), Rx only, Leiter Compounding Health, 13796 Compark Blvd, Englewood, CO 80112, NDC 71449-157-70
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0072-2024·2023-11-01
Vancomycin Hydrochloride IV Bags Recalled Nationwide for Labeling Issue
Denver Solutions, LLC is recalling 25,908 Vancomycin HCI IV bags distributed nationwide due to a labeling issue. Affected lots include products with expiration dates from October 2023 through January 2024.
Product
VANCOmycin HCI PF, 1.5 g added to 0.9% Sodium Chloride 250 mL IV Bag, Rx only, Leiters Compounding Health, 13796 Compark Blvd, Englewood, CO 80112, NDC 71449-029-68.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0445-2023·2023-03-15
FDA Recalls Phenylephrine IV Solution for Manufacturing Practice Deviations
Denver Solutions recalls 8,136 units of Phenylephrine HCl IV solution nationwide due to manufacturing practice deviations. The FDA classified this Class II recall as affecting prescription injectable solutions distributed to hospitals and government facilities.
Product
Phenylephrine HCl 20 mg (80 mcg/mL) added to 0.9% Sodium Chloride 250 mL IV Bag, Rx only, Leiters Compounding Health 13796 Compark Blvd Englewood CO 80112, NDC 71449-148-94
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0444-2023·2023-03-15
FDA Drug Recall: Phenylephrine IV Bags Recalled for Manufacturing Deviations
Denver Solutions recalls 1,212 units of Phenylephrine HCl IV bags nationwide due to Current Good Manufacturing Practice (CGMP) deviations. The voluntary recall affects products distributed across the U.S. including government facilities.
Product
Phenylephrine HCl 40 mg (160 mcg/mL) added to 0.9% Sodium Chloride 250 mL IV Bag, Leiter Compounding Health 13796 Compark Blvd Englewood CO 80112, NDC 71449-150-82
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0443-2023·2023-03-15
FDA Class II: Phenylephrine Injection Recalled for Manufacturing Deviations
Denver Solutions is recalling 325,300 units of Phenylephrine HCl injection due to Current Good Manufacturing Practice deviations. The product was distributed nationwide, including to government facilities.
Product
Phenylephrine HCl 1mg per 10mL (100 mcg/mL) 10 mL syringes, Rx only, Leiters 13796 Compark Blvd Englewood CO 80112, NDC 71449-001-15
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0442-2023·2023-03-15
Phenylephrine HCl syringe recalled for manufacturing practice deviations
Phenylephrine HCl syringe recalled for manufacturing practice deviations. 13,445 units distributed nationwide were recalled by Denver Solutions, LLC.
Product
Phenylephrine HCl 0.5 mg per 5 mL (100 mcg/mL), 5 mL Syringe, Rx only, Leiters 13796 Compark Blvd Englewood CO 80112, NDC 71449-001-11
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0288-2022·2021-12-29
Moxifloxacin 1 mg/mL Solution Label Mix-up Recall
Denver Solutions, LLC (doing business as Leiters Health) is recalling Moxifloxacin 1 mg/mL intracameral injection solution because vials labeled as 1 mg/mL may actually contain 5 mg/mL, creating a serious dosing error risk.
Product
Moxifloxacin, 1 mg/mL, 1mL in 2mL vial, solution for intracameral injection, 10 vials/carton, Rx only, Leiters 13796 Compark Blvd, Englewood, CO 80112, (800) 292-6772, NDC 71449-096-42
Category
Drug
Distribution
Distributed nationwide