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Denver Solutions, LLC DBA Leiters Health

Complete recall history across all FDA and CPSC categories — 22 total recalls

Denver Solutions, LLC DBA Leiters Health appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Drug Recalls (22)

FDA drug safety enforcement actions by Denver Solutions, LLC DBA Leiters Health

Date Product Reason Class
Mar 31, 2025 PHENYLephrine HCl in 0.9% Sodium Chloride, 0.5 mg per 5mL (100 mcg/mL), 5 mL ... Lack of Assurance of Sterility: Leaking/damaged syringes. Class II
Mar 31, 2025 Ketamine HCl 50mg per 5mL (10 mg per mL), 5mL Single Dose Syringe, Rx only, ... Lack of Assurance of Sterility: Leaking/damaged syringes. Class II
Mar 31, 2025 Glycopyrrolate, 1mg per 5mL, (0.2 mg/mL), Single Dose 5 mL syringe, Rx only, ... Lack of Assurance of Sterility: Leaking/damaged syringes. Class II
Mar 31, 2025 dexmedeTOMIDine HCl PF, in 0.9% Sodium Chloride, 20 mcg (base) per 5mL, (4 mc... Lack of Assurance of Sterility: Leaking/damaged syringes. Class II
Mar 31, 2025 Rocuronium Bromide 50 mg per 5mL (10mg per mL), 5mL Single Dose Syringe, Rx ... Lack of Assurance of Sterility: Leaking/damaged syringes. Class II
Feb 20, 2024 Moxifloxacin PF, 1mg/ml, in Sterile Balanced Salt Solution (BSS) Sterile inje... Presence of Particulate Matter: glass vials from the manufacturer showed sign... Class II
Feb 20, 2024 Lidocaine HCL 1% (10mg/mL), PHENYLephrine HCL 1.5% (15mg/mL), 1 ml in a Sing... Presence of Particulate Matter: glass vials from the manufacturer showed sign... Class II
Feb 20, 2024 Moxifloxacin 5mg/ml, 1 ml in a Single- Dose Vial, Rx Only, Leiters 13796 Comp... Presence of Particulate Matter: glass vials from the manufacturer showed sign... Class II
Dec 28, 2023 PHENYLephrine HCl 40 mg per 250 mL 0.9% Sodium Chloride (160 mcg per mL), Ite... Superpotent Drug: semi-automated IV bag filling system can malfunction and pr... Class I
Dec 28, 2023 PHENYLephrine HCl 20 mg per 250 mL 0.9% Sodium Chloride (80 mcg per mL), Item... Superpotent Drug: semi-automated IV bag filling system can malfunction and pr... Class I
Dec 28, 2023 FentaNYL citrate PF, 2500 mcg per 250 mL 0.9% Sodium Chloride (10 mcg per mL)... Superpotent Drug: semi-automated IV bag filling system can malfunction and pr... Class I
Dec 28, 2023 VANCOmycin HCl PF 1.5g added to 0.9% Sodium Chloride 250 mL IV bag, Item F320... Superpotent Drug: semi-automated IV bag filling system can malfunction and pr... Class I
Dec 28, 2023 FentaNYL citrate PF, 1000 mcg per 100 mL 0.9% Sodium Chloride (10 mcg per mL)... Superpotent Drug: semi-automated IV bag filling system can malfunction and pr... Class I
Dec 28, 2023 VANCOmycin HCl PF 1.25g added to 0.9% Sodium Chloride 250 mL IV bag, Item F32... Superpotent Drug: semi-automated IV bag filling system can malfunction and pr... Class I
Oct 4, 2023 Oxytocin synthetic, 30 Units added to 0.9% Sodium Chloride 500mL IV Bag (0.06... Labeling: Not Elsewhere Classified Class III
Oct 4, 2023 VANCOmycin HCI PF, 1.5 g added to 0.9% Sodium Chloride 250 mL IV Bag, Rx only... Labeling: Not Elsewhere Classified Class III
Oct 4, 2023 VANCOmycin HCI PF, 1.25 g added to 0.9% Sodium Chloride 250 mL IV Bag, Rx onl... Labeling: Not Elsewhere Classified Class III
Feb 21, 2023 Phenylephrine HCl 20 mg (80 mcg/mL) added to 0.9% Sodium Chloride 250 mL IV B... CGMP DEVIATIONS Class II
Feb 21, 2023 Phenylephrine HCl 1mg per 10mL (100 mcg/mL) 10 mL syringes, Rx only, Leiters... CGMP DEVIATIONS Class II
Feb 21, 2023 Phenylephrine HCl 0.5 mg per 5 mL (100 mcg/mL), 5 mL Syringe, Rx only, Leiter... CGMP DEVIATIONS Class II
Feb 21, 2023 Phenylephrine HCl 40 mg (160 mcg/mL) added to 0.9% Sodium Chloride 250 mL IV ... CGMP DEVIATIONS Class II
Nov 29, 2021 Moxifloxacin, 1 mg/mL, 1mL in 2mL vial, solution for intracameral injection, ... Labeling: Label Mix-up: Vials labeled as moxifloxacin 1 mg/mL may actually co... Class II

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

Yes. You can search for any company using the firm/manufacturer pages for each category: Food Firms, Drug Firms, Device Firms, or Product Manufacturers. You can also use the search functionality on any browse page to find recalls by company name.

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