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Cipla USA, Inc. FDA Recalls
23 recalls on file across drugs, 1 of them Class I and 21 still open. This firm is not matched to a listed company.
Newest first
Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| Cinacalcet Hydrochloride Tablets, 30 mg, 30-count bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga, India;Class IIJun 29, 2026cGMP Deviations: presence of N-nitroso-cinacalcet, above the |
| Cinacalcet Hydrochloride Tablets, 60 mg, 30-count bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga, India;Class IIJun 29, 2026cGMP Deviations: presence of N-nitroso-cinacalcet, above the |
| Cinacalcet Hydrochloride Tablets, 90 mg, 30-count bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga, India;Class IIJun 29, 2026cGMP Deviations: presence of N-nitroso-cinacalcet, above the |
| Cinacalcet Hydrochloride Tablets, 30 mg, 30 Tablets per bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga, Class IIMar 16, 2026CGMP Deviations; presence N-Nitroso Cinacalcet above the acc |
| Cinacalcet Hydrochloride Tablets, 60 mg, 30 Tablets per bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga, Class IIMar 16, 2026CGMP Deviations; presence N-Nitroso Cinacalcet above the acc |
| Cinacalcet Hydrochloride Tablets, 90 mg, 30 Tablets per bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga, Class IIMar 16, 2026CGMP Deviations; presence N-Nitroso Cinacalcet above the acc |
| Lanreotide Injection, 120 mg*/0.5 mL, Box contains 1 Pre-filled syringe and 1 safety needle, Single dose only, Rx Only, Class IIMar 13, 2026Lack of Assurance of Sterility: Due to an FDA observation at |
| Lanreotide Injection, 120 mg/0.5 mL, Box contains 1 Pre-filled syringe, Single dose only, Rx Only, Manufactured by: PharClass IIMar 13, 2026Lack of Assurance of Sterility: Due to an FDA observation at |
| Nilotinib Capsules, 150 mg per capsule, packaged in cartons, Rx only, Manufactured by: Cipla Ltd., Verna, Goa, India, MaClass IIIFeb 18, 2026Failed Tablet/Capsule Specifications: Observed OOS results a |
| Nilotinib Capsules, 200 mg per capsule, packaged in cartons, Rx only, Manufactured for: Cipla USA, Inc., 10 IndependenceClass IIIFeb 18, 2026Failed Tablet/Capsule Specifications: Observed OOS results a |
| Lanreotide Injection, 120 mg/0.5 mL, 0.5 mL per pre-filled syringe, For deep subcutaneous injection, Rx Only, ManufacturClass IIJan 2, 2026Presence of Particulate Matter. |
| Diclofenac Sodium Topical Gel, 1%, NET WT 100 g (3.53 oz), Manufactured by: DPT Laboratories, Ltd., 307 E Josephine StreClass IIIDec 22, 2025Failed PH Specifications |
| Cinacalcet Hydrochloride Tablets, 60 mg, 30 Tablets per bottle, Rx Only, Manufactured for: Cipla USA, Inc., 10 IndependeClass IINov 14, 2025CGMP Deviations: the presence of a nitrosamine impurity, N-n |
| Cinacalcet Hydrochloride Tablets, 90 mg, 30 Tablets per bottle, Rx Only, Manufactured for: Cipla USA, Inc., 10 IndependeClass IINov 14, 2025CGMP Deviations: the presence of a nitrosamine impurity, N-n |
| Cinacalcet Hydrochloride Tablets, 30 mg, 30 Tablets per bottle, Rx Only, Manufactured for: Cipla USA, Inc., 10 IndependeClass IINov 14, 2025CGMP Deviations: the presence of a nitrosamine impurity, N-n |
| Lanthanum Carbonate chewable tablets, 1000mg*, 10x9 bottles per patient pack carton, Rx Only, Manufactured by: Invagen PClass IIOct 24, 2025Failed stability specifications: Out of specification for ha |
| Lanthanum Carbonate chewable tablets, 1000mg*, 10x9 bottles per patient pack carton, Rx Only, Manufactured by: Invagen PClass IIOct 24, 2025Failed stability specifications: Out of specification for ha |
| Albuterol Sulfate, Inhalation Aerosol, 90 mcg, 200 metered Inhalations, NET CONTENT 6.7 g, Manufactured by: Cipla Ltd, IClass IIIJul 24, 2025Failed Stability Specifications: Out of specification result |
| Budesonide Inhalation Suspension, 0.5mg/2ml, 30 single-dose ampules per carton, five per pouch, RX Only, Manufactured byClass IIJun 30, 2025Lack of Assurance of Sterility: A market complaint was recei |
| Lanthanum Carbonate Chewable Tablets, 1000mg, 10-count bottle, Rx only, Manufactured for Exelan Pharmaceuticals, NDC 762Class IIOct 23, 2024Failed Tablet/Capsule Specifications: Complaints received of |
| Lanthanum Carbonate Chewable Tablets, 1000mg, 10-count bottle, Rx only, Manufactured for Cipla USA, NDC 69097-0936-98Class IIOct 23, 2024Failed Tablet/Capsule Specifications: Complaints received of |
| Ipratropium Bromide and Albuterol Sulfate Inhalation Solution USP, 0.5 mg & 3mg/3mL unit-dose vials, packaged in carton Class IIMar 26, 2024Short fill: Complaints received of less fill volume in respu |
| Albuterol Sulfate Inhalation Aerosol, 90 mcg, 200 Metered Inhalation, net content 6.7 g canister packaged in a box, Rx oClass IJun 27, 2023Defective container: empty inhaler and leakage observed thro |