Albuterol Sulfate Inhalant
FDA Recall NDC 69097-142
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Albuterol Sulfate (NDC 69097-142). A significant event, classified as Class III, was initiated on Jul 24, 2025 by Cipla Usa Inc.. The reported reason for this action was: "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 recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class III Ongoing
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.
Jul 24, 2025
Aug 27, 2025
20352 packs (1x 200 MD)
Recall Profile & Regulatory Data
Event ID
97304
Classification
Class III
Enforcement Status
Ongoing
Recalling Firm
Cipla USA, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
U.S. Nationwide.
Product Description
Albuterol Sulfate, Inhalation Aerosol, 90 mcg, 200 metered Inhalations, NET CONTENT 6.7 g, Manufactured by: Cipla Ltd, Indore, SEZ, Pithampur, India; Manufactured for: Cipla USA, Inc. 10 Independence Boulevard, Suite 300, Warren, NJ 07059, NDC 69097-142-60.
Batch or Lot Expiration Information
Lot# : 4IB0519, Exp. 04/30/2026
Affected Packages Involved in this Recall
69097-142-60Product
Class I Terminated
Defective container: empty inhaler and leakage observed through the inhaler valve due to partially missing bottom seat (gasket).
Jun 27, 2023
Jul 19, 2023
278,538 canisters
Recall Profile & Regulatory Data
Event ID
92616
Classification
Class I
Enforcement Status
Terminated
Recalling Firm
Cipla USA, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the US
Termination Date
Mar 06, 2025
Product Description
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
Batch or Lot Expiration Information
Lot# IB20045, IB20055, IB20056, IB20057, IB20059, IB20072, Exp Nov. 30, 2023
Affected Packages Involved in this Recall
69097-142-60Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
