FDA recall D-0479-2026

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 for recall

Labelling: Illegible label

Distribution

Nationwide within the United States

Key facts

Status

Ongoing

Initiation date

2026-03-17

Report date

2026-04-22

Voluntary/Mandated

Voluntary: Firm initiated

Location

West Columbia, SC, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0479-2026