Budesonide Inhalant
FDA Recall NDC 69097-321

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 Budesonide (NDC 69097-321). A significant event, classified as Class II, was initiated on Jun 30, 2025 by Cipla Usa Inc.. The reported reason for this action was: "Lack of Assurance of Sterility: A market complaint was received for leakage and empty ampoule."

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

D-0541-2025ONGOINGD-1545-2022TERMINATED

June 2025 Class II Recall: Lack of Assurance of Sterility

Recall Number
D-0541-2025
Class II Ongoing
Reason for Recall
Lack of Assurance of Sterility: A market complaint was received for leakage and empty ampoule.
Initiated
Jun 30, 2025
Reported
Jul 30, 2025
Quantity
13,680 ampoules

Recall Profile & Regulatory Data

Event ID
97170
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Cipla USA, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Distributed Nationwide in the USA
Product Description
Budesonide Inhalation Suspension, 0.5mg/2ml, 30 single-dose ampules per carton, five per pouch, RX Only, Manufactured by: Cipla Ltd. Indore SEZ, Pithampur, India. Manufactured for: Ciple USA, Inc. 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC# 69097-319-86 (pouch), 69097-319-87 (carton)
Batch or Lot Expiration Information
Batch# 4IA0505, Exp 09/31/2026
Affected Packages Involved in this Recall
69097-318-86Product
69097-318-87Product
69097-318-32Product
69097-318-53Product
69097-319-86Product
69097-319-87Product
69097-319-32Product
69097-319-53Product
69097-321-86Product
69097-321-87Product
69097-321-32Product
69097-321-53Product

September 2022 Class II Recall: Lack of Assurance of Sterility

Recall Number
D-1545-2022
Class II Terminated
Reason for Recall
Lack of Assurance of Sterility
Initiated
Sep 15, 2022
Reported
Oct 05, 2022
Quantity
641,160 ampules

Recall Profile & Regulatory Data

Event ID
90864
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
CIPLA
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA and Puerto Rico
Termination Date
Jan 10, 2024
Product Description
Budesonide Inhalation Suspension 0.25mg/2mL, For Inhalation Only, Rx Only, 1 envelope x five 2 mL Single Dose Ampules per pouch, Sterile Suspension, Manufactured by: Cipla Ltd., India, Manufactured for Cipla USA Inc., Warren NJ, NDC# 69097-318-86.
Batch or Lot Expiration Information
Lot# s: GA20080, GA20081, GA20094, Exp. 01/2024
Affected Packages Involved in this Recall
69097-318-86Product
69097-318-87Product
69097-318-32Product
69097-318-53Product
69097-319-86Product
69097-319-87Product
69097-319-32Product
69097-319-53Product
69097-321-86Product
69097-321-87Product
69097-321-32Product
69097-321-53Product

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.