Cipla USA Recalls
23 recalls on record · July 19, 2023 to July 8, 2026 · Drugs
Recalls by year
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24
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26
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
July 8, 2026DrugsFDA
Cipla USA, Inc. recalls Cinacalcet Hydrochloride Tablets, 90 mg, 30-count bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga, India;
Hazard: cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).
July 8, 2026DrugsFDA
Cipla USA, Inc. recalls Cinacalcet Hydrochloride Tablets, 60 mg, 30-count bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga, India;
Hazard: cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).
July 8, 2026DrugsFDA
Cipla USA, Inc. recalls Cinacalcet Hydrochloride Tablets, 30 mg, 30-count bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga, India;
Hazard: cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).
April 22, 2026DrugsFDA
Cipla USA, Inc. recalls Cinacalcet Hydrochloride Tablets, 90 mg, 30 Tablets per bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga,
Hazard: CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit
April 22, 2026DrugsFDA
Cipla USA, Inc. recalls Cinacalcet Hydrochloride Tablets, 60 mg, 30 Tablets per bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga,
Hazard: CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit
April 22, 2026DrugsFDA
Cipla USA, Inc. recalls Cinacalcet Hydrochloride Tablets, 30 mg, 30 Tablets per bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga,
Hazard: CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit
April 15, 2026DrugsFDA
Cipla USA, Inc. recalls Lanreotide Injection, 120 mg/0.5 mL, Box contains 1 Pre-filled syringe, Single dose only, Rx Only, Manufactured by: Phar
Hazard: Lack of Assurance of Sterility: Due to an FDA observation at the contract manufacturing site for deficiencies in their visual inspection procedure.
April 15, 2026DrugsFDA
Cipla USA, Inc. recalls Lanreotide Injection, 120 mg*/0.5 mL, Box contains 1 Pre-filled syringe and 1 safety needle, Single dose only, Rx Only,
Hazard: Lack of Assurance of Sterility: Due to an FDA observation at the contract manufacturing site for deficiencies in their visual inspection procedure.
March 11, 2026DrugsFDA
Cipla USA, Inc. recalls Nilotinib Capsules, 200 mg per capsule, packaged in cartons, Rx only, Manufactured for: Cipla USA, Inc., 10 Independence
Hazard: Failed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condition for Description test and Appearance by Visual Inspection test.
March 11, 2026DrugsFDA
Cipla USA, Inc. recalls Nilotinib Capsules, 150 mg per capsule, packaged in cartons, Rx only, Manufactured by: Cipla Ltd., Verna, Goa, India, Ma
Hazard: Failed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condition for Description test and Appearance by Visual Inspection test.
January 28, 2026DrugsFDA
Cipla USA, Inc. recalls Diclofenac Sodium Topical Gel, 1%, NET WT 100 g (3.53 oz), Manufactured by: DPT Laboratories, Ltd., 307 E Josephine Stre
Hazard: Failed PH Specifications
January 21, 2026DrugsFDA
Cipla USA, Inc. recalls Lanreotide Injection, 120 mg/0.5 mL, 0.5 mL per pre-filled syringe, For deep subcutaneous injection, Rx Only, Manufactur
Hazard: Presence of Particulate Matter.
December 17, 2025DrugsFDA
Cipla USA, Inc. recalls Cinacalcet Hydrochloride Tablets, 90 mg, 30 Tablets per bottle, Rx Only, Manufactured for: Cipla USA, Inc., 10 Independe
Hazard: CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
December 17, 2025DrugsFDA
Cipla USA, Inc. recalls Cinacalcet Hydrochloride Tablets, 60 mg, 30 Tablets per bottle, Rx Only, Manufactured for: Cipla USA, Inc., 10 Independe
Hazard: CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
December 17, 2025DrugsFDA
Cipla USA, Inc. recalls Cinacalcet Hydrochloride Tablets, 30 mg, 30 Tablets per bottle, Rx Only, Manufactured for: Cipla USA, Inc., 10 Independe
Hazard: CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
December 17, 2025DrugsFDA
Cipla USA, Inc. recalls Lanthanum Carbonate chewable tablets, 1000mg*, 10x9 bottles per patient pack carton, Rx Only, Manufactured by: Invagen P
Hazard: Failed stability specifications: Out of specification for hardness test
December 17, 2025DrugsFDA
Cipla USA, Inc. recalls Lanthanum Carbonate chewable tablets, 1000mg*, 10x9 bottles per patient pack carton, Rx Only, Manufactured by: Invagen P
Hazard: Failed stability specifications: Out of specification for hardness test
August 27, 2025DrugsFDA
Cipla USA, Inc. recalls Albuterol Sulfate, Inhalation Aerosol, 90 mcg, 200 metered Inhalations, NET CONTENT 6.7 g, Manufactured by: Cipla Ltd, I
Hazard: 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.
July 30, 2025DrugsFDA
Cipla USA, Inc. recalls Budesonide Inhalation Suspension, 0.5mg/2ml, 30 single-dose ampules per carton, five per pouch, RX Only, Manufactured by
Hazard: Lack of Assurance of Sterility: A market complaint was received for leakage and empty ampoule.
November 20, 2024DrugsFDA
Cipla USA, Inc. recalls Lanthanum Carbonate Chewable Tablets, 1000mg, 10-count bottle, Rx only, Manufactured for Exelan Pharmaceuticals, NDC 762
Hazard: Failed Tablet/Capsule Specifications: Complaints received of crushed and broken tablets.
November 20, 2024DrugsFDA
Cipla USA, Inc. recalls Lanthanum Carbonate Chewable Tablets, 1000mg, 10-count bottle, Rx only, Manufactured for Cipla USA, NDC 69097-0936-98
Hazard: Failed Tablet/Capsule Specifications: Complaints received of crushed and broken tablets.
May 1, 2024DrugsFDA
Cipla USA, Inc. recalls Ipratropium Bromide and Albuterol Sulfate Inhalation Solution USP, 0.5 mg & 3mg/3mL unit-dose vials, packaged in carton
Hazard: Short fill: Complaints received of less fill volume in respule and few drops of liquid observed in the intact pouch.
July 19, 2023DrugsFDA
Cipla USA, Inc. recalls Albuterol Sulfate Inhalation Aerosol, 90 mcg, 200 Metered Inhalation, net content 6.7 g canister packaged in a box, Rx o
Hazard: Defective container: empty inhaler and leakage observed through the inhaler valve due to partially missing bottom seat (gasket).