Cipla USA, Inc. Provisional
FDA Flags (23)
Class II RecallJul 2026
Cipla USA, Inc.
Cinacalcet Hydrochloride Tablets, 30 mg, 30-count bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga, India;
Classification: Class II
Class II RecallJul 2026
Cipla USA, Inc.
Cinacalcet Hydrochloride Tablets, 90 mg, 30-count bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga, India;
Classification: Class II
Class II RecallJul 2026
Cipla USA, Inc.
Cinacalcet Hydrochloride Tablets, 60 mg, 30-count bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga, India;
Classification: Class II
Class II RecallApr 2026
Cipla USA, Inc.
Cinacalcet Hydrochloride Tablets, 30 mg, 30 Tablets per bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga,
Classification: Class II
Class II RecallApr 2026
Cipla USA, Inc.
Cinacalcet Hydrochloride Tablets, 90 mg, 30 Tablets per bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga,
Classification: Class II
Class II RecallApr 2026
Cipla USA, Inc.
Cinacalcet Hydrochloride Tablets, 60 mg, 30 Tablets per bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga,
Classification: Class II
Class II RecallApr 2026
Cipla USA, Inc.
Lanreotide Injection, 120 mg/0.5 mL, Box contains 1 Pre-filled syringe, Single dose only, Rx Only, Manufactured by: Phar
Classification: Class II
Class II RecallApr 2026
Cipla USA, Inc.
Lanreotide Injection, 120 mg*/0.5 mL, Box contains 1 Pre-filled syringe and 1 safety needle, Single dose only, Rx Only,
Classification: Class II
Class III RecallMar 2026
Cipla USA, Inc.
Nilotinib Capsules, 150 mg per capsule, packaged in cartons, Rx only, Manufactured by: Cipla Ltd., Verna, Goa, India, Ma
Classification: Class III
Class III RecallMar 2026
Cipla USA, Inc.
Nilotinib Capsules, 200 mg per capsule, packaged in cartons, Rx only, Manufactured for: Cipla USA, Inc., 10 Independence
Classification: Class III
Class III RecallJan 2026
Cipla USA, Inc.
Diclofenac Sodium Topical Gel, 1%, NET WT 100 g (3.53 oz), Manufactured by: DPT Laboratories, Ltd., 307 E Josephine Stre
Classification: Class III
Class II RecallJan 2026
Cipla USA, Inc.
Lanreotide Injection, 120 mg/0.5 mL, 0.5 mL per pre-filled syringe, For deep subcutaneous injection, Rx Only, Manufactur
Classification: Class II
Class II RecallDec 2025
Cipla USA, Inc.
Lanthanum Carbonate chewable tablets, 1000mg*, 10x9 bottles per patient pack carton, Rx Only, Manufactured by: Invagen P
Classification: Class II
Class II RecallDec 2025
Cipla USA, Inc.
Cinacalcet Hydrochloride Tablets, 90 mg, 30 Tablets per bottle, Rx Only, Manufactured for: Cipla USA, Inc., 10 Independe
Classification: Class II
Class II RecallDec 2025
Cipla USA, Inc.
Cinacalcet Hydrochloride Tablets, 30 mg, 30 Tablets per bottle, Rx Only, Manufactured for: Cipla USA, Inc., 10 Independe
Classification: Class II
Class II RecallDec 2025
Cipla USA, Inc.
Lanthanum Carbonate chewable tablets, 1000mg*, 10x9 bottles per patient pack carton, Rx Only, Manufactured by: Invagen P
Classification: Class II
Class II RecallDec 2025
Cipla USA, Inc.
Cinacalcet Hydrochloride Tablets, 60 mg, 30 Tablets per bottle, Rx Only, Manufactured for: Cipla USA, Inc., 10 Independe
Classification: Class II
Class III RecallAug 2025
Cipla USA, Inc.
Albuterol Sulfate, Inhalation Aerosol, 90 mcg, 200 metered Inhalations, NET CONTENT 6.7 g, Manufactured by: Cipla Ltd, I
Classification: Class III
Class II RecallJul 2025
Cipla USA, Inc.
Budesonide Inhalation Suspension, 0.5mg/2ml, 30 single-dose ampules per carton, five per pouch, RX Only, Manufactured by
Classification: Class II
Class II RecallNov 2024
Cipla USA, Inc.
Lanthanum Carbonate Chewable Tablets, 1000mg, 10-count bottle, Rx only, Manufactured for Cipla USA, NDC 69097-0936-98
Classification: Class II
Class II RecallNov 2024
Cipla USA, Inc.
Lanthanum Carbonate Chewable Tablets, 1000mg, 10-count bottle, Rx only, Manufactured for Exelan Pharmaceuticals, NDC 762
Classification: Class II
Class II RecallMay 2024
Cipla USA, Inc.
Ipratropium Bromide and Albuterol Sulfate Inhalation Solution USP, 0.5 mg & 3mg/3mL unit-dose vials, packaged in carton
Classification: Class II
Class I RecallJul 2023
Cipla USA, Inc.
Albuterol Sulfate Inhalation Aerosol, 90 mcg, 200 Metered Inhalation, net content 6.7 g canister packaged in a box, Rx o
Classification: Class I