CLASS II ONGOING Drug recall · Reported 30 Apr 2025 · FDA Enforcement Report
PHENYLephrine HCl in 0.9% Sodium Chloride, 0.5 mg recalled
Denver Solutions is recalling PHENYLephrine HCl in 0.9% Sodium Chloride, 0.5 mg per (100 mcg/mL) Single Dose Syringe, distributed nationwide in the US. The recall was initiated on 31 Mar 2025 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0372-2025
- FDA event ID
- 96607
- Recalling firm
- Denver Solutions, Englewood, CO
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 31 Mar 2025
- FDA classified
- 18 Apr 2025
- Reported
- 30 Apr 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Cold & Cough Medicine
Timeline
| 31 Mar 2025 | Recall initiated by company | |
| 18 Apr 2025 | Classified by FDA | +18 days |
| 30 Apr 2025 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lack of Assurance of Sterility: Leaking/damaged syringes.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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,
Where it was distributed
Nationwide in the U.S.A
Questions about this recall
Why was it recalled?
Lack of Assurance of Sterility: Leaking/damaged syringes.
Which lots are affected?
Lot #: 2431349A, Exp.: 6/16/2025
Where was it sold?
Nationwide in the U.S.A
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
4 other products · FDA event 96607This product is part of a recall event; the main page for the event is Rocuronium Bromide 50 mg per (10mg per mL) Single Dose Syringe recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Rocuronium Bromide 50 mg per (10mg per mL) Single Dose Syringe recalled | Denver Solutions | Sterility | Nationwide | |
| CLASS II | dexmedeTOMIDine HCl PF, in 0.9% Sodium Chloride, 20 mcg recalled | Denver Solutions | Sterility | Nationwide | |
| CLASS II | Glycopyrrolate, 1mg per, (0.2 mg/mL), Single Dose syringe recalled | Denver Solutions | Sterility | Nationwide | |
| CLASS II | Ketamine HCl 50mg per (10 mg per mL) Single Dose Syringe recalled | Denver Solutions | Sterility | Nationwide |
More recalls from Denver Solutions
All 22| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Ketamine HCl 50mg per (10 mg per mL) Single Dose Syringe recalled | Denver Solutions | Sterility | Nationwide |
| Drug | CLASS II | Glycopyrrolate, 1mg per, (0.2 mg/mL), Single Dose syringe recalled | Denver Solutions | Sterility | Nationwide |
| Drug | CLASS II | dexmedeTOMIDine HCl PF, in 0.9% Sodium Chloride, 20 mcg recalled | Denver Solutions | Sterility | Nationwide |
| Drug | CLASS II | Rocuronium Bromide 50 mg per (10mg per mL) Single Dose Syringe recalled | Denver Solutions | Sterility | Nationwide |
| Drug | CLASS II | Moxifloxacin PF, 1mg/ml, in Sterile Balanced Salt Solution recalled | Denver Solutions | Particulate Matter | Nationwide |
Other Phenylephrine recalls
All 122| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Phenylephrine Hydrochloride Injectable Solution, 40mg recalled | Wells Pharma of Houston | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS I | Phenylephrine HCl Injection, USP 100 mg/ (10 mg/mL) vials recalled | Provepharm | Particulate Matter | Nationwide |
| Drug | CLASS II | phenylephrine in 0.9% Sodium Chloride Inj, 1mg per (100 mcg/mL) recalled | Hikma Injectables USA | Sterility | Nationwide |
| Drug | CLASS I | Phenylephrine in 0.9% Sodium Chloride Injection recalled | Hikma Injectables USA | Labeling Errors | 5 states |
| Drug | CLASS II | Phenylephrine HCl, 1000 mcg/ Total Volume per syringe, Intravenous recalled | SSM Health Care St. Louis | Sterility | MO |