Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Cipla Limited | Indore, India | Makes it, tests it, packages it and labels it | Serious problems, FDA actionFeb 17, 2023 · 6 inspections, 1 with FDA action |
| Cipla Limited | Raigad, India | Makes the active ingredient and tests it | Problems found, fixed voluntarilyApr 4, 2024 · 7 inspections |
| InvaGen Pharmaceuticals Inc. | Fall River, MA, United States | Makes it, tests it, packages it and labels it | No problems foundMay 1, 2023 · 1 inspection |
Recalls
- Jul 24, 2025 · Class III · Cipla USA, Inc.
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.
Lots: Lot#: 4IB0519, Exp. 04/30/2026 - Jun 27, 2023 · Class I · Cipla USA, Inc.
Defective container: empty inhaler and leakage observed through the inhaler valve due to partially missing bottom seat (gasket).
Lots: Lot # IB20045, IB20055, IB20056, IB20057, IB20059, IB20072, Exp Nov. 30, 2023
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Albuterol: every company that makes it
- Form
- inhalant, respiratory (inhalation)
- Strength
- 90 ug
- Approval
- ANDA ANDA209959
- On the market since
- Apr 8, 2020
- Package NDCs
69097-142-60- Official label
- DailyMed (National Library of Medicine), updated May 20, 2026
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