CLASS III ONGOING Drug recall · Reported 27 Aug 2025 · FDA Enforcement Report
Albuterol Sulfate, Inhalation Aerosol, 90 mcg recalled by Cipla USA
Cipla USA is recalling Albuterol Sulfate, Inhalation Aerosol, 90 mcg, 200 metered Inhalations, NET Content, distributed nationwide in the US. The recall was initiated on 24 Jul 2025 and the FDA has classified it as Class III.
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-0593-2025
- FDA event ID
- 97304
- Recalling firm
- Cipla USA, Warren, NJ
- Brand
- Albuterol Sulfate
- Manufacturer
- Cipla USA Inc.
- Classification
- Class III
- Status
- Ongoing
- Recall initiated
- 24 Jul 2025
- FDA classified
- 20 Aug 2025
- Reported
- 27 Aug 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Inhalers & Asthma Medication
Timeline
| 24 Jul 2025 | Recall initiated by company | |
| 20 Aug 2025 | Classified by FDA | +27 days |
| 27 Aug 2025 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Stability Specifications: Out of specification results was observed in Induction Port during the analysis of Particle size distribution at the 12-month time point.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Albuterol Sulfate, Inhalation Aerosol, 90 mcg, 200 metered Inhalations, NET CONTENT 6.7 g, Manufactured by: Cipla Ltd, Indore, SEZ, Pithampur, India; Manufactured for: Cipla USA, Inc. 10 Independence Boulevard, Suite 300, Warren, NJ 07059, NDC 69097-142-60.
Where it was distributed
U.S. Nationwide.
Questions about this recall
Why was it recalled?
Failed Stability Specifications: Out of specification results was observed in Induction Port during the analysis of Particle size distribution at the 12-month time point.
Which lots are affected?
Lot#: 4IB0519, Exp. 04/30/2026
Where was it sold?
U.S. Nationwide.
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 III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
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 Cipla USA
All 23| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Cinacalcet Hydrochloride Tablets, 60 mg recalled by Cipla USACinacalcet | Cipla USA | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Cinacalcet Hydrochloride Tablets, 90 mg recalled by Cipla USACinacalcet | Cipla USA | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Cinacalcet Hydrochloride Tablets, 30 mg recalled by Cipla USACinacalcet | Cipla USA | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Cinacalcet Hydrochloride Tablets, 60 mg recalled by Cipla USACinacalcet | Cipla USA | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Cinacalcet Hydrochloride Tablets, 90 mg recalled by Cipla USACinacalcet | Cipla USA | Nitrosamine Impurity | Nationwide |
Other Albuterol recalls
All 30| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Albuterol Sulfate Inhalation Solution, 0.5%, 25 mg recalled | Nephron SC | Other | 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 |