Albuterol Sulfate — Class III drug recall D-0593-2025
Ongoing recall by Cipla USA, Inc., reported 2025-08-27, distributed nationwide. Failed Stability Specifications: Out of specification results was observed in Induction Port during the analys
| Recall number | D-0593-2025 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cipla USA, Inc., Warren, NJ, United States |
| Recall initiated | 2025-07-24 |
| Classified | 2025-08-20 |
| Reported by FDA | 2025-08-27 |
| Distributed | Nationwide (US) |
| Reason classes | specification failure |
| NDC | 69097-0142, 69097-0142-60 |
| Lot numbers | 4IB0519 |
| Expiration dates | 2026-04-30 |
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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0593-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.