Denver Solutions, LLC DBA Leiters Health: FDA recalls

FDA enforcement reports name Denver Solutions, LLC DBA Leiters Health as the recalling firm in 6 events. The events have 22 product records. The recalls started from 2021 to 2025. All the events are drug recalls.

See the 6 events

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Enforcement events

6 events, newest first.

FDA enforcement events of Denver Solutions, LLC DBA Leiters Health
Initiated	Product (first record)	Type	Class	Records	Status
31 Mar 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	Drug	Class II	5	Ongoing
20 Feb 2024	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	Drug	Class II	3	Ongoing
28 Dec 2023	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.	Drug	Class I	6	Ongoing
4 Oct 2023	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	Drug	Class III	3	Terminated
21 Feb 2023	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	Drug	Class II	4	Terminated
29 Nov 2021	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	Drug	Class II	1	Terminated

An event with 1 product record and a class that is not Class I has no page. It has a row in this table.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Recalling firm: The firm that the FDA record names for a recall.

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Type and class

Denver Solutions, LLC DBA Leiters Health: events for each product type
Type		Events
Drug		6

Denver Solutions, LLC DBA Leiters Health: events in each class
Class		Events
Class II		4
Class I		1
Class III		1

Share of the events of the firm in Class I: 17%
Share of all events on the register in Class I: 18%
Events with the status Ongoing: 3

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Events by year

FDA enforcement events of Denver Solutions, LLC DBA Leiters Health, by the year that the recall started. The largest year is 2023, with 3 events.

Official channels

FDA enforcement reportsThe FDA search of the weekly enforcement reports.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA: report a problemThe FDA page that shows where a report about a product goes.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

Cite this page

Recall Register. Denver Solutions, LLC DBA Leiters Health: FDA recalls. https://recallregister.com/firm/denver-solutions-llc-dba-leiters-health/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
State of the firm address: CO

The firm name is the spelling in the FDA records. A company with 2 spellings has 2 pages.

A firm with more products can have more recalls. This site does not compare one firm with a different firm. How the register is made. Report an error.

Questions

Which classes do the FDA recalls of Denver Solutions, LLC DBA Leiters Health have?: Class II: 4 events. Class I: 1 event. Class III: 1 event. The class is for the product of a recall. It is not a class of the firm.
What is the newest FDA recall of Denver Solutions, LLC DBA Leiters Health?: FDA event 96607, which the firm started on 31 Mar 2025. The first product in the record is: 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
How many FDA recalls of Denver Solutions, LLC DBA Leiters Health have the status Ongoing?: 3 events have the status Ongoing in the openFDA file. openFDA says about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.