Albuterol Sulfate Inhalation Aerosol — Class I drug recall D-0938-2023
Terminated recall by Cipla USA, Inc., reported 2023-07-19, distributed nationwide. Defective container: empty inhaler and leakage observed through the inhaler valve due to partially missing bot
| Recall number | D-0938-2023 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cipla USA, Inc., Warren, NJ, United States |
| Recall initiated | 2023-06-27 |
| Classified | 2023-07-21 |
| Reported by FDA | 2023-07-19 |
| Terminated | 2025-03-06 |
| Distributed | Nationwide (US) |
| Quantity | 278,538 canisters |
| Reason classes | packaging |
| NDC | 69097-0142, 69097-0142-60 |
| Lot numbers | IB20045, IB20055, IB20056, IB20057, IB20059, IB20072 |
| Expiration dates | 2023-11-30 |
Product
Albuterol Sulfate Inhalation Aerosol, 90 mcg, 200 Metered Inhalation, net content 6.7 g canister packaged in a box, Rx only, Manufactured by: Cipla Ltd, Indore SE Z, Pithampur, India, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ, 07059, NDC 69097-142-60
Reason for recall
Defective container: empty inhaler and leakage observed through the inhaler valve due to partially missing bottom seat (gasket).
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-0938-2023. 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.