FDA Recall D-0541-2025

Cipla USA, Inc. · Warren, NJ

Class II Ongoing 318 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

Product

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)

Lot / code: Batch # 4IA0505, Exp 09/31/2026

Quantity: 13,680 ampoules

Reason for recall

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

Recall record

Recall number: D-0541-2025
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Distributed Nationwide in the USA
Recall initiated: 2025-06-30
Classified by FDA Center: 2025-07-22
FDA published: 2025-07-30
Recalling firm: Cipla USA, Inc.
Firm location: Warren, NJ

Drug identification

Brand name(s): BUDESONIDE
Generic name(s): BUDESONIDE
Manufacturer(s): Cipla USA Inc.
NDC(s): 69097-318, 69097-319, 69097-321
Route(s): ORAL

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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