Albuterol Sulfate Inhalation Solution recall
FDA recall D-0479-2026 · initiated Mar 17, 2026
Nephron SC, LLC recalled Albuterol Sulfate Inhalation Solution in Mar 2026 — an FDA Class II recall (D-0479-2026) because Labelling: Illegible label.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Labelling: Illegible label
Labelling, packaging or a product mix-up
The wrong information — or the wrong medicine — ended up in the pack. A mix-up is a manufacturing failure that can still be dangerous to swallow.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 146,280 vials
Details
- 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.
- Recalling company
- Nephron SC, LLC
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide within the United States
- Initiated
- Mar 17, 2026
- FDA report date
- Apr 22, 2026
Frequently asked
- Was Albuterol Sulfate Inhalation Solution recalled?
- Nephron SC, LLC recalled Albuterol Sulfate Inhalation Solution in Mar 2026 — an FDA Class II recall (D-0479-2026) because Labelling: Illegible label. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Albuterol Sulfate Inhalation Solution recalled?
- Per the FDA enforcement record, the reason for recall D-0479-2026 was: Labelling: Illegible label
- Is a recalled Albuterol Sulfate Inhalation Solution dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Albuterol Sulfate Inhalation Solution are affected?
- Distributed: Nationwide within the United States. The recall covers these lots — Lot AB6001, exp date 1/15/2027. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0479-2026.