Cipla USA, Inc.
6 federal recalls on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for Cipla USA, Inc. and translate it into plain English — free weekly digest, optional same-day alerts.
- 2025-08-27FDA-DrugClass IIIAlbuterol 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.
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.
- 2025-07-30FDA-DrugClass IIBudesonide 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)
Lack of Assurance of Sterility: A market complaint was received for leakage and empty ampoule.
- 2024-11-20FDA-DrugClass IILanthanum Carbonate Chewable Tablets, 1000mg, 10-count bottle, Rx only, Manufactured for Exelan Pharmaceuticals, NDC 76282-0478-90
Failed Tablet/Capsule Specifications: Complaints received of crushed and broken tablets.
- 2024-11-20FDA-DrugClass IILanthanum Carbonate Chewable Tablets, 1000mg, 10-count bottle, Rx only, Manufactured for Cipla USA, NDC 69097-0936-98
Failed Tablet/Capsule Specifications: Complaints received of crushed and broken tablets.
- 2024-05-01FDA-DrugClass IIIpratropium Bromide and Albuterol Sulfate Inhalation Solution USP, 0.5 mg & 3mg/3mL unit-dose vials, packaged in carton containing 30 vials ( 6 pouches of 5 - 3 mL vials), Rx only, Manufactured by: Cipla Ltd., Indore SEZ, Pithampur, India, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059, NDC 69097-173-53
Short fill: Complaints received of less fill volume in respule and few drops of liquid observed in the intact pouch.
- 2023-07-19FDA-DrugClass IAlbuterol 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
Defective container: empty inhaler and leakage observed through the inhaler valve due to partially missing bottom seat (gasket).
Get notified about new Cipla USA, Inc. recalls
Free weekly digest. We email when a new federal recall affects Cipla USA, Inc. or anything else in your household.
Get the Sunday Brief