Reported Aug 27, 2025 · Ongoing
Albuterol Sulfate, Inhalation Aerosol, 90 mcg, 200 metered Inhalations, NET CONTENT 6.7 g, Manufactured by: Cipla Ltd,…
Cipla USA, Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Cipla USA, Inc. · 10 Independence Blvd · Warren, NJ · 07059-2730
Is this the product you have?
Albuterol SulfateInhalation Aerosol90 mcg200 metered InhalationsNET CONTENT 6.7 g
- Manufactured byCipla Ltd, Indore, SEZ, Pithampur, India
- Manufactured for
Cipla USAInc. 10 Independence BoulevardSuite 300WarrenNJ 07059NDC 69097-142-60
- Lot codes and dates
Lot#: 4IB0519Exp. 04/30/2026
- Amount recalled
- 20352 packs (1x 200 MD)
Where it was sold
- Nationwide
Why it was recalled
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.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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