CLASS II Drug recall · Reported 15 Mar 2023 · FDA Enforcement Report

Phenylephrine HCl 0.5 mg per (100 mcg/mL) Syringe recalled

Denver Solutions is recalling Phenylephrine HCl 0.5 mg per (100 mcg/mL) Syringe, distributed nationwide in the US. The recall was initiated on 21 Feb 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot #: 2230960, Exp date 3/12/2023; 2231080, Exp date 4/9/2023.
Quantity recalled13,445 units

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-0442-2023
FDA event ID
91762
Recalling firm
Denver Solutions, Englewood, CO
Classification
Class II
Status
Terminated
Recall initiated
21 Feb 2023
FDA classified
7 Mar 2023
Reported
15 Mar 2023
Type
Voluntary: Firm initiated
Customers notified by
E-Mail

Timeline

21 Feb 2023Recall initiated by company
7 Mar 2023Classified by FDA+14 days
15 Mar 2023Published in enforcement report+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

CGMP DEVIATIONS

Product as listed by the FDA

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

Where it was distributed

Nationwide within the United States including VA or other Government facilities

Nationwide Virginia

Questions about this recall

Why was it recalled?

CGMP DEVIATIONS

Which lots are affected?

Lot #: 2230960, Exp date 3/12/2023; 2231080, Exp date 4/9/2023.

Where was it sold?

Nationwide within the United States including VA or other Government facilities

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

3 other products · FDA event 91762

This product is part of a recall event; the main page for the event is Phenylephrine HCl 40 mg (160 mcg/mL) added to 0.9% Sodium recalled.

ReportedClassRecallCompanyReasonWhere
CLASS IIPhenylephrine HCl 40 mg (160 mcg/mL) added to 0.9% Sodium recalledDenver SolutionsManufacturing (CGMP) DeviationsNationwide
CLASS IIPhenylephrine HCl 1mg per (100 mcg/mL) syringes recalledDenver SolutionsManufacturing (CGMP) DeviationsNationwide
CLASS IIPhenylephrine HCl 20 mg (80 mcg/mL) added to 0.9% Sodium Chloride IV recalledDenver SolutionsManufacturing (CGMP) DeviationsNationwide

More recalls from Denver Solutions

All 22
ReportedClassRecallCompanyReasonWhere
DrugCLASS IIPHENYLephrine HCl in 0.9% Sodium Chloride, 0.5 mg recalledDenver SolutionsSterilityNationwide
DrugCLASS IIKetamine HCl 50mg per (10 mg per mL) Single Dose Syringe recalledDenver SolutionsSterilityNationwide
DrugCLASS IIGlycopyrrolate, 1mg per, (0.2 mg/mL), Single Dose syringe recalledDenver SolutionsSterilityNationwide
DrugCLASS IIdexmedeTOMIDine HCl PF, in 0.9% Sodium Chloride, 20 mcg recalledDenver SolutionsSterilityNationwide
DrugCLASS IIRocuronium Bromide 50 mg per (10mg per mL) Single Dose Syringe recalledDenver SolutionsSterilityNationwide

Other Phenylephrine Per recalls

All 4
ReportedClassRecallCompanyReasonWhere
DrugCLASS IIPhenylephrine HCl 1mg per (100 mcg/mL) syringes recalledDenver SolutionsManufacturing (CGMP) DeviationsNationwide
DrugCLASS IIPhenylephrine HCl Injection 40 mg recalled by Athenex Pharma SolutionsAthenex Pharma SolutionsOtherNationwide
DrugCLASS IIPhenylephrine HCl Injection 50 mg recalled by Athenex Pharma SolutionsAthenex Pharma SolutionsOtherNationwide