Budesonide Inhalation Suspension 0 — Class II drug recall D-1545-2022
Terminated recall by CIPLA, reported 2022-10-05, distributed nationwide. Lack of Assurance of Sterility
| Recall number | D-1545-2022 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | CIPLA, Warren, NJ, United States |
| Recall initiated | 2022-09-15 |
| Classified | 2022-09-27 |
| Reported by FDA | 2022-10-05 |
| Terminated | 2024-01-10 |
| Distributed | Nationwide (US) |
| Quantity | 641,160 ampules |
| Reason classes | sterility |
| NDC | 69097-0318, 69097-0318-32, 69097-0318-53, 69097-0318-86, 69097-0318-87, 69097-0319, 69097-0319-32, 69097-0319-53, 69097-0319-86, 69097-0319-87, 69097-0321, 69097-0321-32, 69097-0321-53, 69097-0321-86, 69097-0321-87 |
| Lot numbers | GA20080, GA20081, GA20094 |
| Expiration dates | 2024-01 |
Product
Budesonide Inhalation Suspension 0.25mg/2mL, For Inhalation Only, Rx Only, 1 envelope x five 2 mL Single Dose Ampules per pouch, Sterile Suspension, Manufactured by: Cipla Ltd., India, Manufactured for Cipla USA Inc., Warren NJ, NDC# 69097-318-86.
Reason for recall
Lack of Assurance of Sterility
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-1545-2022. 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.