Leiters Health Phenylephrine HCl Recall: FDA Class II

Why it was recalled

CGMP DEVIATIONS

Product description

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

Lot numbers, UPCs & expiration codes

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

Where it was sold

Nationwide within the United States including VA or other Government facilities

What to do if you have this product

Compare the lot number and expiration date on your package with the codes above.
Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
If you have symptoms you think are related, contact your doctor. In an emergency call 911.
Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number: D-0442-2023
Classification: Class II
Status: Terminated
Recall initiated: Feb 21, 2023
FDA report date: Mar 15, 2023
Quantity: 13,445 units
Recall type: Voluntary: Firm initiated
Recalling firm: Denver Solutions, LLC DBA Leiters Health

Original FDA data

Every field from FDA enforcement report D-0442-2023, exactly as published.

Show all FDA fields

City: Englewood
State: CO
Status: Terminated
Country: United States
Event ID: 91762
Address: 13796 Compark Blvd
Code information: Lot #: 2230960, Exp date 3/12/2023; 2231080, Exp date 4/9/2023.
Postal code: 80112-7145
Report date: Mar 15, 2023
Product type: Drugs
Recall number: D-0442-2023
Classification: Class II
Recalling firm: Denver Solutions, LLC DBA Leiters Health
Product quantity: 13,445 units
Termination date: Jan 11, 2024
Reason for recall: CGMP DEVIATIONS
Voluntary / mandated: Voluntary: Firm initiated
Product description: 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
Distribution pattern: Nationwide within the United States including VA or other Government facilities
Recall initiation date: Feb 21, 2023
Initial firm notification: E-Mail
Center classification date: Mar 7, 2023

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0442-2023, published Mar 15, 2023. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: Oct 2, 2026. Content last changed: Oct 2, 2026.

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

Denver Solutions, LLC DBA Leiters Health Phenylephrine HCl 0 Recall

Summary