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Drug FDA Class II Ongoing Contamination / non-sterility

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

Cipla USA, Inc. Published Jul 30, 2025

Risk level

Class II

May cause a temporary or reversible health problem; slight chance of serious harm.

Severity score 60/100

What should you do?

  • Check whether you have this product, using the lot codes, UPCs, and dates listed below.
  • Do not eat, serve, or sell the affected product.
  • Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
  • Contact Cipla USA, Inc. or your place of purchase with questions, and see the source record below for full details.
Reason for recall

Lack of Assurance of Sterility: A market complaint was received for leakage and empty ampoule.

Hazards

Lack of Sterility Assurance · primary

Affected products (1)

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)

BUDESONIDE · 13,680 ampoules

NDC: 69097-318, 69097-319, 69097-321, 69097-318-86, 69097-318-87, 69097-318-32, 69097-318-53, 69097-319-86, 69097-319-87, 69097-319-32, 69097-319-53, 69097-321-86, 69097-321-87, 69097-321-32, 69097-321-53
Code info: Batch # 4IA0505, Exp 09/31/2026

Affected areas

Nationwide

Timeline

  1. Initiated
    Jun 30, 2025
  2. Published
    Jul 30, 2025
Recall number
D-0541-2025
Agency
U.S. Food and Drug Administration
Country
US
Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.