Cipla USA, Inc.

FDA Regulatory Profile

Summary

Total Recalls
15 (1 Class I)
510(k) Clearances
0
Inspections
0
Compliance Actions
0

Known Names

cipla usa, cipla usa inc

Recent Recalls

NumberClassProductDate
D-0382-2026Class IIINilotinib Capsules, 200 mg per capsule, packaged in cartons, Rx only, Manufactured for: Cipla USA, IFebruary 18, 2026
D-0381-2026Class IIINilotinib Capsules, 150 mg per capsule, packaged in cartons, Rx only, Manufactured by: Cipla Ltd., VFebruary 18, 2026
D-0290-2026Class IILanreotide Injection, 120 mg/0.5 mL, 0.5 mL per pre-filled syringe, For deep subcutaneous injection,January 2, 2026
D-0291-2026Class IIIDiclofenac Sodium Topical Gel, 1%, NET WT 100 g (3.53 oz), Manufactured by: DPT Laboratories, Ltd., December 22, 2025
D-0226-2026Class IICinacalcet Hydrochloride Tablets, 90 mg, 30 Tablets per bottle, Rx Only, Manufactured for: Cipla USANovember 14, 2025
D-0225-2026Class IICinacalcet Hydrochloride Tablets, 60 mg, 30 Tablets per bottle, Rx Only, Manufactured for: Cipla USANovember 14, 2025
D-0224-2026Class IICinacalcet Hydrochloride Tablets, 30 mg, 30 Tablets per bottle, Rx Only, Manufactured for: Cipla USANovember 14, 2025
D-0217-2026Class IILanthanum Carbonate chewable tablets, 1000mg*, 10x9 bottles per patient pack carton, Rx Only, ManufaOctober 24, 2025
D-0218-2026Class IILanthanum Carbonate chewable tablets, 1000mg*, 10x9 bottles per patient pack carton, Rx Only, ManufaOctober 24, 2025
D-0593-2025Class IIIAlbuterol Sulfate, Inhalation Aerosol, 90 mcg, 200 metered Inhalations, NET CONTENT 6.7 g, ManufactuJuly 24, 2025
D-0541-2025Class IIBudesonide Inhalation Suspension, 0.5mg/2ml, 30 single-dose ampules per carton, five per pouch, RX OJune 30, 2025
D-0043-2025Class IILanthanum Carbonate Chewable Tablets, 1000mg, 10-count bottle, Rx only, Manufactured for Cipla USA, October 23, 2024
D-0044-2025Class IILanthanum Carbonate Chewable Tablets, 1000mg, 10-count bottle, Rx only, Manufactured for Exelan PharOctober 23, 2024
D-0471-2024Class IIIpratropium Bromide and Albuterol Sulfate Inhalation Solution USP, 0.5 mg & 3mg/3mL unit-dose vials,March 26, 2024
D-0938-2023Class IAlbuterol Sulfate Inhalation Aerosol, 90 mcg, 200 Metered Inhalation, net content 6.7 g canister pacJune 27, 2023