Why it was recalled
Labelling: Illegible label
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.
Lot numbers, UPCs & expiration codes
Lot AB6001, exp date 1/15/2027
Where it was sold
Nationwide within the United States
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0479-2026
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Mar 17, 2026
- FDA report date
- Apr 22, 2026
- Quantity
- 146,280 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Nephron SC, LLC
Original FDA data
Every field from FDA enforcement report D-0479-2026, exactly as published.
Show all FDA fields
- City
- West Columbia
- State
- SC
- Status
- Ongoing
- Country
- United States
- Event ID
- 98596
- Address
- 4500 12th Street Ext
- Code information
- Lot AB6001, exp date 1/15/2027
- Postal code
- 29172-3025
- Report date
- Apr 22, 2026
- Product type
- Drugs
- Recall number
- D-0479-2026
- Classification
- Class II
- Recalling firm
- Nephron SC, LLC
- Product quantity
- 146,280 vials
- Reason for recall
- Labelling: Illegible label
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- Nationwide within the United States
- Recall initiation date
- Mar 17, 2026
- Center classification date
- Apr 14, 2026