Albuterol Sulfate Inhalation Solution…

Date

April 22, 2026

Risk class

Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)

Status

Ongoing

Filed by

Nephron SC, LLC

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.

Reason

Labelling: Illegible label

Distribution pattern

Nationwide within the United States

Quantity

146,280 vials

Codes and lots

Lot AB6001, exp date 1/15/2027

Recall started

March 17, 2026

Recall number

D-0479-2026

What should I do? Medicine recall: what to do

Source: FDA · Drug enforcement report, recall number D-0479-2026. The agency record governs; check it and the company before acting.