--- title: "Denver Solutions, LLC DBA Leiters Health Recalls: Agency-Reported Status and History (Oct 1, 2026) | Is It on Recall" description: "Search Denver Solutions, LLC DBA Leiters Health recall records, lots, firms and dates. Reported status can be incomplete; use the linked agency notice for current instructions." url: https://isitonrecall.com/brand/denver-solutions-llc-dba-leiters-health/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Home](https://isitonrecall.com/) / Brand archive # Denver Solutions, LLC DBA Leiters Health recall records **14** reported ongoing 22 records in this archive. Latest source date Mar 31, 2025. FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination. Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## Records and reported status Mar 31, 2025 FDA drug enforcement ### [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](https://isitonrecall.com/recall/fda-drug-d-0370-2025-glycopyrrolate-1mg-per-5ml-0-2-mg-ml-single-dose-5-ml-syringe-rx-only-leiters-health-13796-compark-b/) Lack of Assurance of Sterility: Leaking/damaged syringes. Class II Reported ongoing Distribution: Nationwide in the U.S.A [Official source for Glycopyrrolate, 1mg per 5mL, (0.2 mg/mL), Single Dose 5 mL syringe, Rx only, Leiters Health, 1379...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0370-2025%22) Mar 31, 2025 FDA drug enforcement ### [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, C...](https://isitonrecall.com/recall/fda-drug-d-0371-2025-dexmedetomidine-hcl-pf-in-0-9-sodium-chloride-20-mcg-base-per-5ml-4-mcg-base-per-ml-5ml-single-dose/) Lack of Assurance of Sterility: Leaking/damaged syringes. Class II Reported ongoing Distribution: Nationwide in the U.S.A [Official source for dexmedeTOMIDine HCl PF, in 0.9% Sodium Chloride, 20 mcg (base) per 5mL, (4 mcg (base) per mL), 5m...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0371-2025%22) Mar 31, 2025 FDA drug enforcement ### [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: 71449-00...](https://isitonrecall.com/recall/fda-drug-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/) Lack of Assurance of Sterility: Leaking/damaged syringes. Class II Reported ongoing Distribution: Nationwide in the U.S.A [Official source for PHENYLephrine HCl in 0.9% Sodium Chloride, 0.5 mg per 5mL (100 mcg/mL), 5 mL Single Dose Syringe,...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0372-2025%22) Mar 31, 2025 FDA drug enforcement ### [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](https://isitonrecall.com/recall/fda-drug-d-0373-2025-ketamine-hcl-50mg-per-5ml-10-mg-per-ml-5ml-single-dose-syringe-rx-only-leiters-health-13796-compark/) Lack of Assurance of Sterility: Leaking/damaged syringes. Class II Reported ongoing Distribution: Nationwide in the U.S.A [Official source for Ketamine HCl 50mg per 5mL (10 mg per mL), 5mL Single Dose Syringe, Rx only, Leiters Health, 13796...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0373-2025%22) Mar 31, 2025 FDA drug enforcement ### [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](https://isitonrecall.com/recall/fda-drug-d-0374-2025-rocuronium-bromide-50-mg-per-5ml-10mg-per-ml-5ml-single-dose-syringe-rx-only-leiters-health-13796-co/) Lack of Assurance of Sterility: Leaking/damaged syringes. Class II Reported ongoing Distribution: Nationwide in the U.S.A [Official source for Rocuronium Bromide 50 mg per 5mL (10mg per mL), 5mL Single Dose Syringe, Rx only, Leiters Health,...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0374-2025%22) Feb 20, 2024 FDA drug enforcement ### [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, ND...](https://isitonrecall.com/recall/fda-drug-d-0361-2024-moxifloxacin-pf-1mg-ml-in-sterile-balanced-salt-solution-bss-sterile-injection-intracameral-use-only/) Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delamination. Class II Reported ongoing Distribution: Nationwide in the USA [Official source for Moxifloxacin PF, 1mg/ml, in Sterile Balanced Salt Solution (BSS) Sterile injection, Intracameral ...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0361-2024%22) Feb 20, 2024 FDA drug enforcement ### [Moxifloxacin 5mg/ml, 1 ml in a Single- Dose Vial, Rx Only, Leiters 13796 Compark Blvd, Englewood, CO 80112, NDC 71449-097-42](https://isitonrecall.com/recall/fda-drug-d-0362-2024-moxifloxacin-5mg-ml-1-ml-in-a-single-dose-vial-rx-only-leiters-13796-compark-blvd-englewood-co-80112/) Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delamination. Class II Reported ongoing Distribution: Nationwide in the USA [Official source for Moxifloxacin 5mg/ml, 1 ml in a Single- Dose Vial, Rx Only, Leiters 13796 Compark Blvd, Englewood,...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0362-2024%22) Feb 20, 2024 FDA drug enforcement ### [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](https://isitonrecall.com/recall/fda-drug-d-0363-2024-lidocaine-hcl-1-10mg-ml-phenylephrine-hcl-1-5-15mg-ml-1-ml-in-a-single-dose-vial-rx-only-leiters-137/) Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delamination. Class II Reported ongoing Distribution: Nationwide in the USA [Official source for Lidocaine HCL 1% (10mg/mL), PHENYLephrine HCL 1.5% (15mg/mL), 1 ml in a Single- Dose Vial, RX Onl...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0363-2024%22) Dec 28, 2023 FDA drug enforcement ### [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.](https://isitonrecall.com/recall/fda-drug-d-0277-2024-fentanyl-citrate-pf-1000-mcg-per-100-ml-0-9-sodium-chloride-10-mcg-per-ml-item-f3355-for-iv-use-only/) Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags. Class I Reported ongoing Distribution: Nationwide within the United States [Official source for FentaNYL citrate PF, 1000 mcg per 100 mL 0.9% Sodium Chloride (10 mcg per mL), Item F3355, for IV...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0277-2024%22) Dec 28, 2023 FDA drug enforcement ### [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.](https://isitonrecall.com/recall/fda-drug-d-0278-2024-fentanyl-citrate-pf-2500-mcg-per-250-ml-0-9-sodium-chloride-10-mcg-per-ml-item-f3342-for-iv-use-only/) Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags. Class I Reported ongoing Distribution: Nationwide within the United States [Official source for FentaNYL citrate PF, 2500 mcg per 250 mL 0.9% Sodium Chloride (10 mcg per mL), Item F3342, for IV...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0278-2024%22) Dec 28, 2023 FDA drug enforcement ### [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.](https://isitonrecall.com/recall/fda-drug-d-0279-2024-phenylephrine-hcl-20-mg-per-250-ml-0-9-sodium-chloride-80-mcg-per-ml-item-f3360-for-iv-use-only-leit/) Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags. Class I Reported ongoing Distribution: Nationwide within the United States [Official source for PHENYLephrine HCl 20 mg per 250 mL 0.9% Sodium Chloride (80 mcg per mL), Item F3360, for IV use o...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0279-2024%22) Dec 28, 2023 FDA drug enforcement ### [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.](https://isitonrecall.com/recall/fda-drug-d-0280-2024-phenylephrine-hcl-40-mg-per-250-ml-0-9-sodium-chloride-160-mcg-per-ml-item-f3352-for-iv-use-only-lei/) Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags. Class I Reported ongoing Distribution: Nationwide within the United States [Official source for PHENYLephrine HCl 40 mg per 250 mL 0.9% Sodium Chloride (160 mcg per mL), Item F3352, for IV use ...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0280-2024%22) Dec 28, 2023 FDA drug enforcement ### [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.](https://isitonrecall.com/recall/fda-drug-d-0281-2024-vancomycin-hcl-pf-1-25g-added-to-0-9-sodium-chloride-250-ml-iv-bag-item-f3206-for-iv-use-only-leiter/) Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags. Class I Reported ongoing Distribution: Nationwide within the United States [Official source for VANCOmycin HCl PF 1.25g added to 0.9% Sodium Chloride 250 mL IV bag, Item F3206, for IV use only;...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0281-2024%22) Dec 28, 2023 FDA drug enforcement ### [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.](https://isitonrecall.com/recall/fda-drug-d-0282-2024-vancomycin-hcl-pf-1-5g-added-to-0-9-sodium-chloride-250-ml-iv-bag-item-f3208-for-iv-use-only-leiters/) Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags. Class I Reported ongoing Distribution: Nationwide within the United States [Official source for VANCOmycin HCl PF 1.5g added to 0.9% Sodium Chloride 250 mL IV bag, Item F3208, for IV use only; ...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0282-2024%22) Oct 4, 2023 FDA drug enforcement ### [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 714...](https://isitonrecall.com/recall/fda-drug-d-0070-2024-oxytocin-synthetic-30-units-added-to-0-9-sodium-chloride-500ml-iv-bag-0-06-units-per-ml-rx-only-leit/) Labeling: Not Elsewhere Classified Class III Reported terminated Distribution: USA Nationwide [Official source for Oxytocin synthetic, 30 Units added to 0.9% Sodium Chloride 500mL IV Bag (0.06 Units per mL), Rx o...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0070-2024%22) Oct 4, 2023 FDA drug enforcement ### [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.](https://isitonrecall.com/recall/fda-drug-d-0071-2024-vancomycin-hci-pf-1-25-g-added-to-0-9-sodium-chloride-250-ml-iv-bag-rx-only-leiters-compounding-heal/) Labeling: Not Elsewhere Classified Class III Reported terminated Distribution: USA Nationwide [Official source for VANCOmycin HCI PF, 1.25 g added to 0.9% Sodium Chloride 250 mL IV Bag, Rx only, Leiters Compoundi...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0071-2024%22) Oct 4, 2023 FDA drug enforcement ### [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.](https://isitonrecall.com/recall/fda-drug-d-0072-2024-vancomycin-hci-pf-1-5-g-added-to-0-9-sodium-chloride-250-ml-iv-bag-rx-only-leiters-compounding-healt/) Labeling: Not Elsewhere Classified Class III Reported terminated Distribution: USA Nationwide [Official source for VANCOmycin HCI PF, 1.5 g added to 0.9% Sodium Chloride 250 mL IV Bag, Rx only, Leiters Compoundin...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0072-2024%22) Feb 21, 2023 FDA drug enforcement ### [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](https://isitonrecall.com/recall/fda-drug-d-0442-2023-phenylephrine-hcl-0-5-mg-per-5-ml-100-mcg-ml-5-ml-syringe-rx-only-leiters-13796-compark-blvd-englewo/) CGMP DEVIATIONS Class II Reported terminated Distribution: Nationwide within the United States including VA or other Government facilities [Official source for Phenylephrine HCl 0.5 mg per 5 mL (100 mcg/mL), 5 mL Syringe, Rx only, Leiters 13796 Compark Blvd...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0442-2023%22) Feb 21, 2023 FDA drug enforcement ### [Phenylephrine HCl 1mg per 10mL (100 mcg/mL) 10 mL syringes, Rx only, Leiters 13796 Compark Blvd Englewood CO 80112, NDC 71449-001-15](https://isitonrecall.com/recall/fda-drug-d-0443-2023-phenylephrine-hcl-1mg-per-10ml-100-mcg-ml-10-ml-syringes-rx-only-leiters-13796-compark-blvd-englewoo/) CGMP DEVIATIONS Class II Reported terminated Distribution: Nationwide within the United States including VA or other Government facilities [Official source for Phenylephrine HCl 1mg per 10mL (100 mcg/mL) 10 mL syringes, Rx only, Leiters 13796 Compark Blvd E...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0443-2023%22) Feb 21, 2023 FDA drug enforcement ### [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](https://isitonrecall.com/recall/fda-drug-d-0444-2023-phenylephrine-hcl-40-mg-160-mcg-ml-added-to-0-9-sodium-chloride-250-ml-iv-bag-leiter-compounding-hea/) CGMP DEVIATIONS Class II Reported terminated Distribution: Nationwide within the United States including VA or other Government facilities [Official source for Phenylephrine HCl 40 mg (160 mcg/mL) added to 0.9% Sodium Chloride 250 mL IV Bag, Leiter Compound...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0444-2023%22) ## Reasons in these listed records - Lack of Assurance of Sterility: Leaking/damaged syringes. - Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delamination. - Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags. - Labeling: Not Elsewhere Classified These examples come from this result page and are not a ranking of every recall reason. ## Checking Denver Solutions, LLC DBA Leiters Health ### Is there a recall on denver solutions, llc dba leiters health right now? This archive contains 22 records, including 14 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product. ### How do I check my package or product? Compare the product, firm and lot, date, model or serial identifiers with the notice. [Use the label-check guide](https://isitonrecall.com/guides/read-lot-codes/) if you need help locating an identifier. ### Does a matching name mean every item is included? A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall. ### What if the search finds no matching record? This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. [Check source coverage](https://isitonrecall.com/sources/) and the agency's current notices. ### Where can I find older records? Use [monthly archives](https://isitonrecall.com/archives/) or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page. ## Keep checking [Search Denver Solutions, LLC DBA Leiters Health](https://isitonrecall.com/check/?q=Denver%20Solutions%2C%20LLC%20DBA%20Leiters%20Health) [Browse related products](https://isitonrecall.com/products/) [Review source dates](https://isitonrecall.com/sources/)