Recall archive / FDA drug enforcement
Albuterol Sulfate Inhalation Aerosol, 90 mcg, 200 Metered Inhalation, net content 6.7 g canister packaged in a box, R... — FDA record D-0938-2023
Reported terminated
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Jun 27, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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
- Defective container: empty inhaler and leakage observed through the inhaler valve due to partially missing bottom seat (gasket).
- Classification
- Class I
- Recalling firm
- Cipla USA, Inc.
- Quantity
- 278,538 canisters
- Agency-reported status
- Terminated
- Source record identifier
- D-0938-2023
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Lot # IB20045, IB20055, IB20056, IB20057, IB20059, IB20072, Exp Nov. 30, 2023 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Nationwide in the US
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Jul 19, 2023
- Recall initiation date
- Jun 27, 2023
- Center classification date
- Jul 21, 2023
- Termination date
- Mar 6, 2025
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.