Unrated Drug recall · FDA · Published February 21, 2023

Leiters Health IV Bag Recall: CGMP Deviations in Phenylephrine Solution

Leiters Health recalls phenylephrine HCl IV bags due to CGMP deviations. Affected units have specific lot and expiration dates. Contact for remedy details.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-0444-2023Drug Leiters Health ›

Recall notice

CGMP DEVIATIONS

Take action

Contact the company

Recalling firmDenver Solutions, LLC DBA Leiters Health13796 Compark Blvd · Englewood, CO 80112-7145

✎ GovInfoNow plain-language explainer

Leiters Health is recalling phenylephrine HCl IV bags that were manufactured with CGMP deviations. This means the product may not meet safety standards and could pose risks during medical use. Read more at govinfonow.com/recall/33865-leiters-health-iv-bag-recall-cgmp-deviations-in-phenylephrine-solution.

Source Summary by GovInfoNow · govinfonow.com/recall/33865-leiters-health-iv-bag-recall-cgmp-deviations-in-phenylephrine-solution · Updated August 18, 2026 · FDA enforcement record: FDA #D-0444-2023

Cite this page

“Leiters Health IV Bag Recall: CGMP Deviations in Phenylephrine Solution.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/33865-leiters-health-iv-bag-recall-cgmp-deviations-in-phenylephrine-solution. Based on FDA recall #D-0444-2023 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0444-2023%22&limit=1).

The FDA announced on Feb. 21, 2023, that Denver Solutions, LLC DBA Leiters Health voluntarily recalled Phenylephrine HCl IV bags due to current good manufacturing practice deviations. The recall affects 1,212 units distributed nationwide.

How to tell if you have it

Brand: Leiters Health
Product: Phenylephrine HCl 40 mg (160 mcg/mL) added to 0.9% Sodium Chloride 250 mL IV Bag
NDC: 71449-150-82
Lot #: 2231017
Exp. Date: 3/12/2023

The hazard

The recall was issued due to current good manufacturing practice deviations, according to the FDA.

Context

GovInfoNow's records show Denver Solutions, LLC DBA Leiters Health has five other recalls on record since Nov. 29, 2021. Other recent recalls of similar products include Wells Pharma phenylephrine injectable solution (April 1, 2026), Wells Pharma Fentanyl Citrate Recall (April 1, 2026), and Wells Pharma Fentanyl Citrate Injectable Solution Recall (April 1, 2026).

How to tell if you have this one

Check for the product name 'Phenylephrine HCl 40 mg (160 mcg/mL) added to 0.9% Sodium Chloride 250 mL IV Bag' with lot number 2231017 and expiration date 3/12/2023.

Brand
Leiters Health
Category
Drug

FDA recall event · 4 products

All 4 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Terminated
Distribution
Nationwide within the United States including VA or other Government facilities

Recall number	Product, codes & lots	Quantity
D-0442-2023	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 #: 2230960, Exp date 3/12/2023; 2231080, Exp date 4/9/2023.	13,445 units
D-0443-2023	Phenylephrine HCl 1mg per 10mL (100 mcg/mL) 10 mL syringes, Rx only, Leiters 13796 Compark Blvd Englewood CO 80112, NDC 71449-001-15; Lot #: 2230895, Exp. Date 3/5/2023; 2230911, Exp. Date 3/11/2023; 2230913, Exp. Date 3/18/2023; 2230994, Exp. Date 3/27/2023; 2231006, Exp. Date 4/1/2023; 2231109, Exp. Date 4/19/2023; 2231126, Exp. Date 5/6/2023; 2231134, Exp. Date 5/10/2023; 2231140, Exp. Date 5/14/2023; 2231142, Exp. Date 5/20/2023; 2231156, Exp. Date 5/29/2023; 2231273, Exp. Date 6/3/2023; 2231285, Exp. Date 6/10/2023; 2231299, Exp. Date 6/17/2023; 2231331, Exp. Date 6/26/2023; 2330014, Exp. Date 7/9/2023; 2330025, Exp. Date 7/15/2023	325,300 units
D-0444-2023	Phenylephrine HCl 40 mg (160 mcg/mL) added to 0.9% Sodium Chloride 250 mL IV Bag, Leiter Compounding Health 13796 Compark Blvd Englewood CO 80112, NDC 71449-150-82; Lot #: 2231017, Exp. Date 3/12/2023	1212 units
D-0445-2023	Phenylephrine HCl 20 mg (80 mcg/mL) added to 0.9% Sodium Chloride 250 mL IV Bag, Rx only, Leiters Compounding Health 13796 Compark Blvd Englewood CO 80112, NDC 71449-148-94; Lot #: 2231026, Exp. Date 2/23/2023; 2231051, Exp. Date 3/11/2023; 2231156, Exp. Date 5/29/2023; 2231163, Exp. Date 3/26/2023; 223130, Exp. Date 4 5/7/2023; 2231308, Exp. Date 5/11/2023	8,136 units

Based on the official FDA remedy

What to do — step by step

Check Product Details
Look for the lot number 2231017 and expiration date 3/12/2023 on the IV bag.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “Nationwide within the United States including VA or other Government facilities” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 11 months after the firm started it.

Feb 21, 2023Firm started the recall
Mar 7, 2023FDA classified it Class II
Mar 15, 2023Published in FDA’s Enforcement Report
Jan 11, 2024FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

Is this product safe to use?

The recall indicates CGMP deviations, meaning the product may not meet safety standards. The manufacturer has not provided a remedy, so it is not safe to use.

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Link to this recall

<a href="https://govinfonow.com/recall/33865-leiters-health-iv-bag-recall-cgmp-deviations-in-phenylephrine-solution">Leiters Health IV Bag Recall: CGMP Deviations in Phenylephrine Solution (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #D-0444-2023 (February 21, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0444-2023 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.