Levalbuterol Inhalation Solution — Class III drug recall D-1078-2015
Terminated recall by Cipla Limited, reported 2015-05-20, distributed nationwide. Failed Impurities/Degradation Specifications: Product is out of specification for a known degradant.
| Recall number | D-1078-2015 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cipla Limited, Pithampur, District Dhar, N/A, India |
| Recall initiated | 2015-04-24 |
| Classified | 2015-05-14 |
| Reported by FDA | 2015-05-20 |
| Terminated | 2017-02-14 |
| Distributed | Nationwide (US) |
| Quantity | 140,625 vials |
| Reason classes | specification failure |
| NDC | 43598-0412-25 |
| Lot numbers | FA4022 |
| Expiration dates | 2015-12-20 |
Product
Levalbuterol Inhalation Solution, USP, 0.31 mg/ 3 mL, 3 mL Vials, Rx Only. Manufactured by: Cipla Ltd. Plot 9 & 10, Indure, SEZ, Pithampur, M.P.-454 775, INDIA, Manufactured for: Dr. Reddy's Laboratories, Inc., Princeton NJ 08640. NDC: 43598-412-25.
Reason for recall
Failed Impurities/Degradation Specifications: Product is out of specification for a known degradant.
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-1078-2015. 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.