Home / Recalls / Nephron SC, LLC / D-0479-2026

D-0479-2026 Class II Ongoing

Recalled by Nephron SC, LLC — West Columbia, SC

FDA drug recall D-0479-2026 was initiated by Nephron SC, LLC on Mar 17, 2026 and is designated Class II. Reason for recall: Labelling: Illegible label The recall status is ongoing. Affected quantity: 146,280 vials.

Recall Details

Product Type: Drugs
Report Date: Apr 22, 2026
Initiation Date: Mar 17, 2026
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 146,280 vials

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.

Reason for Recall

Labelling: Illegible label

Distribution Pattern

Nationwide within the United States

Code Information

Lot AB6001, exp date 1/15/2027

Source

Dataset: openFDA drug recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for D-0479-2026
openFDA file date: Nov 3, 2026
Loaded by RegDataLab: Nov 4, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

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