CLASS II ONGOING Drug recall · Reported 22 Apr 2026 · FDA Enforcement Report
Albuterol Sulfate Inhalation Solution, 0.5%, 25 mg recalled
Nephron SC is recalling Albuterol Sulfate Inhalation Solution, 0.5%, 25 mg/ (5 mg/mL*), mL Sterile Unit-Dose Vials, distributed nationwide in the US. The recall was initiated on 17 Mar 2026 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0479-2026
- FDA event ID
- 98596
- Recalling firm
- Nephron SC, West Columbia, SC
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 17 Mar 2026
- FDA classified
- 14 Apr 2026
- Reported
- 22 Apr 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- N/A
- Reason category
- Other Reasons
- Drug class
- Inhalers & Asthma Medication
Timeline
| 17 Mar 2026 | Recall initiated by company | |
| 14 Apr 2026 | Classified by FDA | +28 days |
| 22 Apr 2026 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Labelling: Illegible label
Product as listed by the FDA
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.
Where it was distributed
Nationwide within the United States
Questions about this recall
Why was it recalled?
Labelling: Illegible label
Which lots are affected?
Lot AB6001, exp date 1/15/2027
Where was it sold?
Nationwide within the United States
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Nephron SC
All 7| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Sterile Water for Injection, USP, mL Single-Dose Vials recalledSterile Water | Nephron Sc | Manufacturing (CGMP) Deviations | SC |
| Drug | CLASS II | Asthmanefrin Racepinephrine Inhalation Solution recalled by Nephron Sc | Nephron Sc | Packaging Defects | Nationwide |
| Drug | CLASS II | S2 Racepinephrine Inhalation Solution recalled by Nephron ScS2 | Nephron Sc | Packaging Defects | Nationwide |
| Drug | CLASS II | Sterile Water for Injection recalled by Nephron ScSterile Water | Nephron Sc | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | 0.9% Sodium Chloride Injection, USP Single-Dose Container recalledSodium Chloride | Nephron Sc | Manufacturing (CGMP) Deviations | Nationwide |
Other Albuterol recalls
All 30| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Albuterol Sulfate, Inhalation Aerosol, 90 mcg recalled by Cipla USAAlbuterol Sulfate | Cipla USA | Potency & Assay | Nationwide |
| Drug | CLASS II | Airsupra (albuterol and budesonide) inhalation aerosol recalledAirsupra | AsttraZeneca Pharmaceuticals | Packaging Defects | Nationwide |
| Drug | CLASS II | Albuterol Sulfate HFA Inhalation Aerosol recalled by Cardinal HealthcareAlbuterol Sulfate | Cardinal Healthcare | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Albuterol Sulfate IN 90MCG per actuation, 200 Metered Inhalations recalledAlbuterol Sulfate | Cardinal Healthcare | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS I | Albuterol Sulfate Inhalation Aerosol, 90 mcg recalled by Cipla USAAlbuterol Sulfate | Cipla USA | Packaging Defects | Nationwide |