Denver Solutions recalls

Denver Solutions has 22 recalls on record with the FDA and USDA, the earliest in 2021 and the latest reported on 30 Apr 2025. 14 are still ongoing. The most frequent reason is potency & assay.

Total recalls22since 2021

Last 12 months0reported

Class I627% of total

Ongoing14latest 30 Apr 2025

Recalls per month, last 24 months

click a bar for that month

0Nov '24 0 0 0Feb 0 5 0May 0 0 0Aug 0 0 0Nov 0 0 0Feb 0 0 0May 0 0 0Aug 0 0

Severity split

Class I 6 27%Class II 13 59%Class III 3 14%

Why denver solutions is recalled

Product types

By year

2025523%
2024941%
2023732%
202115%

Ongoing denver solutions recalls

14 active

Reported	Class	Recall	Company	Reason	Where
30 Apr 2025Drug	CLASS II	PHENYLephrine HCl in 0.9% Sodium Chloride, 0.5 mg recalled	Denver Solutions	Sterility	Nationwide
30 Apr 2025Drug	CLASS II	Ketamine HCl 50mg per (10 mg per mL) Single Dose Syringe recalled	Denver Solutions	Sterility	Nationwide
30 Apr 2025Drug	CLASS II	Glycopyrrolate, 1mg per, (0.2 mg/mL), Single Dose syringe recalled	Denver Solutions	Sterility	Nationwide
30 Apr 2025Drug	CLASS II	dexmedeTOMIDine HCl PF, in 0.9% Sodium Chloride, 20 mcg recalled	Denver Solutions	Sterility	Nationwide
30 Apr 2025Drug	CLASS II	Rocuronium Bromide 50 mg per (10mg per mL) Single Dose Syringe recalled	Denver Solutions	Sterility	Nationwide
6 Mar 2024Drug	CLASS II	Moxifloxacin PF, 1mg/ml, in Sterile Balanced Salt Solution recalled	Denver Solutions	Particulate Matter	Nationwide

All denver solutions recalls, newest first

22 total

Reported	Class	Recall	Company	Reason	Where
30 Apr 2025Drug	CLASS II	PHENYLephrine HCl in 0.9% Sodium Chloride, 0.5 mg recalled	Denver Solutions	Sterility	Nationwide
30 Apr 2025Drug	CLASS II	Ketamine HCl 50mg per (10 mg per mL) Single Dose Syringe recalled	Denver Solutions	Sterility	Nationwide
30 Apr 2025Drug	CLASS II	Glycopyrrolate, 1mg per, (0.2 mg/mL), Single Dose syringe recalled	Denver Solutions	Sterility	Nationwide
30 Apr 2025Drug	CLASS II	dexmedeTOMIDine HCl PF, in 0.9% Sodium Chloride, 20 mcg recalled	Denver Solutions	Sterility	Nationwide
30 Apr 2025Drug	CLASS II	Rocuronium Bromide 50 mg per (10mg per mL) Single Dose Syringe recalled	Denver Solutions	Sterility	Nationwide
6 Mar 2024Drug	CLASS II	Moxifloxacin PF, 1mg/ml, in Sterile Balanced Salt Solution recalled	Denver Solutions	Particulate Matter	Nationwide
6 Mar 2024Drug	CLASS II	Lidocaine HCL 1% (10mg/mL), PHENYLephrine HCL recalled	Denver Solutions	Particulate Matter	Nationwide
6 Mar 2024Drug	CLASS II	Moxifloxacin 5mg/ml in a Single- Dose Vial recalled by Denver Solutions	Denver Solutions	Particulate Matter	Nationwide
7 Feb 2024Drug	CLASS I	PHENYLephrine HCl 40 mg per 0.9% Sodium Chloride (160 mcg per mL) recalled	Denver Solutions	Potency & Assay	Nationwide
7 Feb 2024Drug	CLASS I	PHENYLephrine HCl 20 mg per 0.9% Sodium Chloride (80 mcg per mL) recalled	Denver Solutions	Potency & Assay	Nationwide
7 Feb 2024Drug	CLASS I	FentaNYL citrate PF, 2500 mcg per 0.9% Sodium Chloride recalled	Denver Solutions	Potency & Assay	Nationwide
7 Feb 2024Drug	CLASS I	VANCOmycin HCl PF added to 0.9% Sodium Chloride IV recalled	Denver Solutions	Potency & Assay	Nationwide
7 Feb 2024Drug	CLASS I	FentaNYL citrate PF, 1000 mcg per 0.9% Sodium Chloride recalled	Denver Solutions	Potency & Assay	Nationwide
7 Feb 2024Drug	CLASS I	VANCOmycin HCl PF added to 0.9% Sodium Chloride IV recalled	Denver Solutions	Potency & Assay	Nationwide
1 Nov 2023Drug	CLASS III	Oxytocin synthetic added to 0.9% Sodium Chloride IV Bag per mL) recalled	Denver Solutions	Foreign Material	Nationwide
1 Nov 2023Drug	CLASS III	VANCOmycin HCI PF added to 0.9% Sodium Chloride IV recalled	Denver Solutions	Foreign Material	Nationwide
1 Nov 2023Drug	CLASS III	VANCOmycin HCI PF added to 0.9% Sodium Chloride IV recalled	Denver Solutions	Foreign Material	Nationwide
15 Mar 2023Drug	CLASS II	Phenylephrine HCl 20 mg (80 mcg/mL) added to 0.9% Sodium Chloride IV recalled	Denver Solutions	Manufacturing (CGMP) Deviations	Nationwide
15 Mar 2023Drug	CLASS II	Phenylephrine HCl 1mg per (100 mcg/mL) syringes recalled	Denver Solutions	Manufacturing (CGMP) Deviations	Nationwide
15 Mar 2023Drug	CLASS II	Phenylephrine HCl 0.5 mg per (100 mcg/mL) Syringe recalled	Denver Solutions	Manufacturing (CGMP) Deviations	Nationwide
15 Mar 2023Drug	CLASS II	Phenylephrine HCl 40 mg (160 mcg/mL) added to 0.9% Sodium recalled	Denver Solutions	Manufacturing (CGMP) Deviations	Nationwide
29 Dec 2021Drug	CLASS II	Moxifloxacin, 1 mg/mL in vial, solution recalled by Denver Solutions	Denver Solutions	Packaging Defects	Nationwide

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.