Cipla Usa recalls
Cipla Usa appears in 24 official U.S. recall notices indexed by RecallRadar, most recently on 2026-10-14.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 24 |
|---|---|
| Published | 2023-07-19 to 2026-10-14 |
| By agency | FDA Drug (24) |
| By classification | Class II (19), Class III (4), Class I (1) |
| By status | ongoing (22), terminated (2) |
| Distribution named in notices | US |
Recalls
- Fosfomycin Tromethamine Granules for Oral Solution, (Equivalent to 3 Grams of Fosfomycin), 1 Single-Dose Sachet, Rx only, Manufactured by:…
FDA Drug · Class II · 2026-10-14 · Cipla Usa
Reason: Failed Impurities/Degradation Specifications - Cinacalcet Hydrochloride Tablets, 60 mg, 30-count bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga, India
FDA Drug · Class II · 2026-07-08 · Cipla Usa
Reason: cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI). - Cinacalcet Hydrochloride Tablets, 90 mg, 30-count bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga, India
FDA Drug · Class II · 2026-07-08 · Cipla Usa
Reason: cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI). - Cinacalcet Hydrochloride Tablets, 30 mg, 30-count bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga, India
FDA Drug · Class II · 2026-07-08 · Cipla Usa
Reason: cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI). - Cinacalcet Hydrochloride Tablets, 30 mg, 30 Tablets per bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga, India
FDA Drug · Class II · 2026-04-22 · Cipla Usa
Reason: CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit - Cinacalcet Hydrochloride Tablets, 60 mg, 30 Tablets per bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga, India
FDA Drug · Class II · 2026-04-22 · Cipla Usa
Reason: CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit - Cinacalcet Hydrochloride Tablets, 90 mg, 30 Tablets per bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga, India
FDA Drug · Class II · 2026-04-22 · Cipla Usa
Reason: CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit - Lanreotide Injection, 120 mg*/0.5 mL, Box contains 1 Pre-filled syringe and 1 safety needle, Single dose only, Rx Only, Manufactured by: Ph…
FDA Drug · Class II · 2026-04-15 · Cipla Usa
Reason: Lack of Assurance of Sterility: Due to an FDA observation at the contract manufacturing site for deficiencies in their visual inspection procedure. - Lanreotide Injection, 120 mg/0.5 mL, Box contains 1 Pre-filled syringe, Single dose only, Rx Only, Manufactured by: Pharmathen Internationa…
FDA Drug · Class II · 2026-04-15 · Cipla Usa
Reason: Lack of Assurance of Sterility: Due to an FDA observation at the contract manufacturing site for deficiencies in their visual inspection procedure. - Nilotinib Capsules, 150 mg per capsule, packaged in cartons, Rx only, Manufactured by: Cipla Ltd., Verna, Goa, India, Manufactured for: Cip…
FDA Drug · Class III · 2026-03-11 · Cipla Usa
Reason: Failed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condition for Description test and Appearance by Visual Inspection test. - Nilotinib Capsules, 200 mg per capsule, packaged in cartons, Rx only, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 3…
FDA Drug · Class III · 2026-03-11 · Cipla Usa
Reason: Failed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condition for Description test and Appearance by Visual Inspection test. - Diclofenac Sodium Topical Gel, 1%, NET WT 100 g (3.53 oz), Manufactured by: DPT Laboratories, Ltd., 307 E Josephine Street, San Antonio, TX…
FDA Drug · Class III · 2026-01-28 · Cipla Usa
Reason: Failed PH Specifications - Lanreotide Injection, 120 mg/0.5 mL, 0.5 mL per pre-filled syringe, For deep subcutaneous injection, Rx Only, Manufactured for: Cipla USA,…
FDA Drug · Class II · 2026-01-21 · Cipla Usa
Reason: Presence of Particulate Matter. - Lanthanum Carbonate chewable tablets, 1000mg*, 10x9 bottles per patient pack carton, Rx Only, Manufactured by: Invagen Pharmaceuticals, Inc…
FDA Drug · Class II · 2025-12-17 · Cipla Usa
Reason: Failed stability specifications: Out of specification for hardness test - Cinacalcet Hydrochloride Tablets, 60 mg, 30 Tablets per bottle, Rx Only, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suit…
FDA Drug · Class II · 2025-12-17 · Cipla Usa
Reason: CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits. - Cinacalcet Hydrochloride Tablets, 30 mg, 30 Tablets per bottle, Rx Only, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suit…
FDA Drug · Class II · 2025-12-17 · Cipla Usa
Reason: CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits. - Lanthanum Carbonate chewable tablets, 1000mg*, 10x9 bottles per patient pack carton, Rx Only, Manufactured by: Invagen Pharmaceuticals, Inc…
FDA Drug · Class II · 2025-12-17 · Cipla Usa
Reason: Failed stability specifications: Out of specification for hardness test - Cinacalcet Hydrochloride Tablets, 90 mg, 30 Tablets per bottle, Rx Only, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suit…
FDA Drug · Class II · 2025-12-17 · Cipla Usa
Reason: CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits. - Albuterol Sulfate, Inhalation Aerosol, 90 mcg, 200 metered Inhalations, NET CONTENT 6.7 g, Manufactured by: Cipla Ltd, Indore, SEZ, Pithamp…
FDA Drug · Class III · 2025-08-27 · Cipla Usa
Reason: 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. - Budesonide Inhalation Suspension, 0.5mg/2ml, 30 single-dose ampules per carton, five per pouch, RX Only, Manufactured by: Cipla Ltd
FDA Drug · Class II · 2025-07-30 · Cipla Usa
Reason: Lack of Assurance of Sterility: A market complaint was received for leakage and empty ampoule. - Lanthanum Carbonate Chewable Tablets, 1000mg, 10-count bottle, Rx only, Manufactured for Cipla USA, NDC 69097-0936-98
FDA Drug · Class II · 2024-11-20 · Cipla Usa
Reason: Failed Tablet/Capsule Specifications: Complaints received of crushed and broken tablets. - Lanthanum Carbonate Chewable Tablets, 1000mg, 10-count bottle, Rx only, Manufactured for Exelan Pharmaceuticals, NDC 76282-0478-90
FDA Drug · Class II · 2024-11-20 · Cipla Usa
Reason: Failed Tablet/Capsule Specifications: Complaints received of crushed and broken tablets. - Ipratropium Bromide and Albuterol Sulfate Inhalation Solution USP, 0.5 mg & 3mg/3mL unit-dose vials, packaged in carton containing 30 vials…
FDA Drug · Class II · 2024-05-01 · Cipla Usa
Reason: Short fill: Complaints received of less fill volume in respule and few drops of liquid observed in the intact pouch. - Albuterol Sulfate Inhalation Aerosol, 90 mcg, 200 Metered Inhalation, net content 6.7 g canister packaged in a box, Rx only, Manufactured b…
FDA Drug · Class I · 2023-07-19 · Cipla Usa
Reason: Defective container: empty inhaler and leakage observed through the inhaler valve due to partially missing bottom seat (gasket).