Albuterol Sulfate recall
FDA recall D-0593-2025 · initiated Jul 24, 2025
Cipla USA, Inc. recalled Albuterol Sulfate in Jul 2025 — an FDA Class III recall (D-0593-2025) because 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.
Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
Why it was 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.
Wrong strength, or it did not keep
The product did not contain what the label promised, or stopped meeting specification before its expiry date. Under-strength medicine can mean an untreated condition.
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: 20352 packs (1x 200 MD)
Details
- Product
- 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.
- Recalling company
- Cipla Limited
- Classification
- Class III
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- U.S. Nationwide.
- Initiated
- Jul 24, 2025
- FDA report date
- Aug 27, 2025
Frequently asked
- Was Albuterol Sulfate recalled?
- Cipla USA, Inc. recalled Albuterol Sulfate in Jul 2025 — an FDA Class III recall (D-0593-2025) because 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. Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
- Why was Albuterol Sulfate recalled?
- Per the FDA enforcement record, the reason for recall D-0593-2025 was: 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.
- Is a recalled Albuterol Sulfate 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. Unlikely to cause harm but violates FDA labeling or manufacturing regulations. 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 are affected?
- Distributed: U.S. Nationwide.. The recall covers these lots — Lot#: 4IB0519, Exp. 04/30/2026. 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-0593-2025.