Albuterol Sulfate Inhalation Solution, 0.5%, 25 mg/5 mL (5 mg/mL*)
Recalled by Nephron SC, LLC
Drug recall
Nephron SC, LLC
Class II — moderate
Using this product might cause a temporary or medically reversible health problem. The chance of serious harm is low.
Nephron SC, LLC has recalled Albuterol Sulfate Inhalation Solution, 0.5%, 25 mg/5 mL (5 mg/mL*), according to data published by the U.S. Food and Drug Administration (FDA). The recall was reported on April 22, 2026 and was initiated on March 17, 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 Albuterol Sulfate Inhalation Solution, 0.5%, 25 mg/5 mL (5 mg/mL*), with approximately 146,280 vials affected. The company behind the recall is Nephron SC, LLC, based in West Columbia, SC. The FDA describes the product as: “Albuterol Sulfate Inhalation Solution, 0.5%, 25 mg/5 mL (5 mg/mL*), 30x5 mL Sterile Unit-Dose Vials, Rx only, nephron 503B Outsourcing facility, 4600 12th Street Extension, West Columbia, SC 29172, NDC 69374-330-05.”
Why was Albuterol Sulfate Inhalation Solution, 0.5%, 25 mg/5 mL (5 mg/mL*) recalled?
According to the FDA, the stated reason for the recall is: “Labelling: Illegible label.”
What should you do?
If you think you may have bought Albuterol Sulfate Inhalation Solution, 0.5%, 25 mg/5 mL (5 mg/mL*), compare it against the product description and identifying codes (Lot AB6001, exp date 1/15/2027) 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 Nephron SC, LLC or your local health authority.
About this recall
This recall was distributed in SC. 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
- April 22, 2026
- Recall started
- March 17, 2026
- Distributed in
- SC
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 Albuterol Sulfate Inhalation Solution, 0.5%, 25 mg/5 mL (5 mg/mL*) recalled?+
According to the FDA: Labelling: Illegible label
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 Albuterol Sulfate Inhalation Solution, 0.5%, 25 mg/5 mL (5 mg/mL*)?+
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.
Opens the U.S. Food and Drug Administration (FDA) data for this recall.
Recall number: D-0479-2026. Information last synced from the FDA on July 5, 2026.