FDA Drugs recall ·

Albuterol Sulfate Inhalation Solution, 0.5%, 25 mg/5 mL (5 mg/mL*)… recall

Recall number
D-0479-2026
Date
(initiated March 17, 2026)
Company / brand
Nephron SC, LLC
4500 12th Street Ext, West Columbia, SC, United States
Category
Drugs › Class II
Classification
Class II
Status
Ongoing
Units affected
146,280 vials
Initiated by
Voluntary: Firm initiated

Read the official FDA notice ↗

Product

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 it recalled?

Labelling: Illegible label

What should you do?

FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.

Product codes & lot numbers

Lot AB6001, exp date 1/15/2027

Distribution

Nationwide within the United States

What does Class II mean?

Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.

Source: FDA (drugs), recall D-0479-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.