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.
FDA recall notice · announced April 22, 2026 · Nephron Sc
Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.
The 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
Notes
Distribution: Nationwide within the United States
Lot/code information: Lot AB6001, exp date 1/15/2027
Quantity: 146,280 vials
Status: Ongoing
Products in this recall event:
- 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, ND (D-0479-2026)
Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.