RecallRadar
ModerateReported May 6, 2026 (8 weeks ago)

fentaNYL Citrate Injectable Solution in 0.9% Sodium Chloride

Recalled by Wells Pharma of Houston LLC

Drug recall

Wells Pharma of Houston LLC

Class II — moderate

Using this product might cause a temporary or medically reversible health problem. The chance of serious harm is low.

Wells Pharma of Houston LLC has recalled fentaNYL Citrate Injectable Solution in 0.9% Sodium Chloride, according to data published by the U.S. Food and Drug Administration (FDA). The recall was reported on May 6, 2026 and was initiated on April 1, 2026. It is classified as a Class II recall, which means using this product might cause a temporary or medically reversible health problem. The chance of serious harm is low.

Below is a plain-English summary of what was recalled, why it was recalled, how to tell whether you have the affected product, and what steps you can take. For the complete and most current details, you can view the FDA record linked further down this page.

What was recalled?

This recall covers fentaNYL Citrate Injectable Solution in 0.9% Sodium Chloride, with approximately 150 syringes affected. The company behind the recall is Wells Pharma of Houston LLC, based in Houston, TX. The FDA describes the product as: “fentaNYL Citrate Injectable Solution in 0.9% Sodium Chloride, 1000 mcg/50mL (20 mcg per mL), well pharma of Houston, NDC 73702-203-65.”

Why was fentaNYL Citrate Injectable Solution in 0.9% Sodium Chloride recalled?

According to the FDA, the stated reason for the recall is: “cGMP deviations.” In plain terms, this recall relates to a manufacturing quality issue (CGMP).

CGMP stands for Current Good Manufacturing Practice — the FDA's quality rules for how medicines must be made, tested, and documented. A CGMP-related recall means the manufacturing process did not meet those standards. It does not automatically mean the medicine is harmful, but the FDA cannot be confident in its quality, so it is removed from the market.

What should you do?

If you think you may have bought fentaNYL Citrate Injectable Solution in 0.9% Sodium Chloride, compare it against the product description and identifying codes (Lot 022326203650432; Exp Date 06/25/2026) before using it. This recall is currently listed as ongoing.

The general guidance for a matching product is to stop using it and follow the instructions in the official FDA recall notice, which may include a repair, replacement, refund, or safe disposal. When in doubt, contact Wells Pharma of Houston LLC or your local health authority.

About this recall

This recall was distributed in TX. RecallRadar summarizes recall information from public FDA data to make it easier to understand. We are an independent service and are not affiliated with the FDA or any government agency, so please always refer to the official source for the authoritative record — and note the “last synced” date shown on this page, since recall details can change over time.

Full recall details

Status
Ongoing
Date reported
May 6, 2026
Recall started
April 1, 2026
Distributed in
TX
What was recalled
fentaNYL Citrate Injectable Solution in 0.9% Sodium Chloride, 1000 mcg/50mL (20 mcg per mL), well pharma of Houston, NDC 73702-203-65.
Why it was recalled (as stated by the FDA)
cGMP deviations.
How to identify the affected product
Lot 022326203650432; Exp Date 06/25/2026
Amount recalled
150 syringes

What you can do

Check whether any product you have matches the description and codes above. If it does, stop using it and follow the instructions in the official recall notice. When in doubt, contact the company or your local health authority.

Quick answers

Why was fentaNYL Citrate Injectable Solution in 0.9% Sodium Chloride recalled?+

According to the FDA: cGMP deviations.

How serious is this recall?+

Class II — moderate. Using this product might cause a temporary or medically reversible health problem. The chance of serious harm is low.

What should I do if I have fentaNYL Citrate Injectable Solution in 0.9% Sodium Chloride?+

Compare your product against the description and identifying codes on this page. If it matches, stop using it and follow the instructions in the official recall notice — this usually means returning it for a refund or discarding it. When in doubt, contact the company or your local health authority.

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View the official FDA record

Opens the U.S. Food and Drug Administration (FDA) data for this recall.

Recall number: D-0506-2026. Information last synced from the FDA on July 5, 2026.

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