FDA Recall D-0479-2026
Nephron SC, LLC · West Columbia, SC
Class II Ongoing 58 days on record
Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.
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
Recall record
- Recall number
D-0479-2026- Classification
- Class II
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- N/A
- Distribution
- Nationwide within the United States
- Recall initiated
- 2026-03-17
- Classified by FDA Center
- 2026-04-14
- FDA published
- 2026-04-22
- Recalling firm
- Nephron SC, LLC
- Firm location
- West Columbia, SC
Operational response
Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.
For the official FDA enforcement record, see FDA's Recall Search.