← FDA ENFORCEMENT
D-0479-2026Class II

Nephron SC, LLC

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm
Nephron SC, LLC
Product type
Drug
Status
Ongoing
Report date
2026-04-22
Distribution
Nationwide within the United States
Firm state
SC
Product quantity
146,280 vials
Initiated by
Voluntary: Firm initiated
Reason for recall

Labelling: Illegible label

Product description

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.

Code / lot info

Lot AB6001, exp date 1/15/2027

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →