Albuterol Sulfate Inhalation Solution Recalled for Illegible Labeling
Key Takeaways
- The US Food and Drug Administration (FDA) is monitoring a voluntary, firm-initiated Class II recall of albuterol sulfate inhalation solution, 0.5% (25 mg/5 mL), involving 146 280 unit-dose vials distributed nationwide and identified as Lot AB6001 (Exp. 01/15/2027).
- The recall was initiated by Nephron SC, LLC (503B outsourcing facility) due to illegible labeling, a quality issue that may lead to temporary or medically reversible adverse health consequences.
- Albuterol inhalation solution is a short-acting beta-agonist (SABA) indicated for the treatment and prevention of bronchospasm, commonly used in outpatient, inpatient, and emergency respiratory care.
The FDA has classified a Class II recall for albuterol sulfate inhalation solution, 0.5% (25 mg/5 mL), packaged as 30 × 5 mL sterile unit-dose vials (NDC 69374-330-05). The product was produced by Nephron SC, LLC, a 503B outsourcing facility located in West Columbia, SC. The recall affects 146 280 vials distributed nationwide in the US, specifically Lot #AB6001, with an expiration date of January 15, 2027. The recall was initiated on March 17, 2026.
The recall was prompted by illegible labeling, which may impair proper product identification, dosing, or administration. The FDA classified the recall as Class II on April 14, 2026, indicating that use of the affected product may cause temporary or medically reversible adverse health consequences, with a low likelihood of serious harm. Although no contamination or formulation defect has been reported, labeling clarity is critical for safe medication use, particularly in acute care settings. No public press release has been issued.
Albuterol sulfate inhalation solution is a short-acting beta-agonist (SABA) indicated for the treatment and prevention of bronchospasm in conditions such as asthma and chronic obstructive pulmonary disease (COPD). It is widely used in nebulized therapy across outpatient, inpatient, and emergency care settings. Pharmacists should identify and quarantine affected Lot #AB6001, remove it from inventory, and ensure replacement with properly labeled product.
Reference
FDA. Enforcement Report. April 15, 2026. Accessed April 16, 2026. https://www.accessdata.fda.gov/scripts/ires/index.cfm
