FDA recall, , Moderate risk
Nephron Albuterol Sulfate Inhalation Solution
Albuterol Sulfate Inhalation Solution has an illegible label.
Summary by Recall Canary from the FDA notice
What happened
Nephron SC, LLC of West Columbia, South Carolina is recalling Albuterol Sulfate Inhalation Solution, 0.5%, 25 mg/5 mL (5 mg/mL*), 30x5 mL Sterile Unit-Dose Vials, Rx only, because of an illegible label. The recall, which began March 17, 2026, covers 146,280 vials distributed nationwide within the United States.
The product is a 503B Outsourcing facility item. The FDA added the recall to its Enforcement Report on April 14, 2026.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medicine recalls:
- Check the FDA or company notice for instructions specific to this product.
- Ask your pharmacist or doctor whether your lot is affected and what to do.
Is yours affected?
Match the NDC and lot code listed under your product.
An NDC (National Drug Code) is usually printed on the drug's label.
Albuterol Sulfate Inhalation Solution
- NDC
- 69374-330-05
- Lot code
- AB6001
Recall details
- Company began the recall
- Sold in
Nationwide within the United States
- Company
- Nephron SC, LLCWest Columbia, South Carolina
- Hazard
- Labeling error
- Risk
Moderate risk
Taking it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98596
- Recall number
- D-0479-2026
- Quantity recalled
- 146,280 vials
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
Summary updated
