--- title: "Cipla USA, Inc. Recalls: Agency-Reported Status and History (Oct 1, 2026) | Is It on Recall" description: "Search Cipla USA, Inc. recall records, lots, firms and dates. Reported status can be incomplete; use the linked agency notice for current instructions." url: https://isitonrecall.com/brand/cipla-usa-inc/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Home](https://isitonrecall.com/) / Brand archive # Cipla USA, Inc. recall records **21** reported ongoing 23 records in this archive. Latest source date Jun 29, 2026. FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination. Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## Records and reported status Jun 29, 2026 FDA drug enforcement ### [Cinacalcet Hydrochloride Tablets, 30 mg, 30-count bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga, India; Manufactured for: Cipla USA, Inc., 10 Independence Boule...](https://isitonrecall.com/recall/fda-drug-d-0661-2026-cinacalcet-hydrochloride-tablets-30-mg-30-count-bottle-rx-only-manufactured-by-cipla-ltd-midc-patalg/) cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI). Class II Reported ongoing Distribution: USA Nationwide [Official source for Cinacalcet Hydrochloride Tablets, 30 mg, 30-count bottle, Rx Only, Manufactured by: Cipla Ltd., M...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0661-2026%22) Jun 29, 2026 FDA drug enforcement ### [Cinacalcet Hydrochloride Tablets, 60 mg, 30-count bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga, India; Manufactured for: Cipla USA, Inc., 10 Independence Boule...](https://isitonrecall.com/recall/fda-drug-d-0675-2026-cinacalcet-hydrochloride-tablets-60-mg-30-count-bottle-rx-only-manufactured-by-cipla-ltd-midc-patalg/) cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI). Class II Reported ongoing Distribution: USA Nationwide [Official source for Cinacalcet Hydrochloride Tablets, 60 mg, 30-count bottle, Rx Only, Manufactured by: Cipla Ltd., M...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0675-2026%22) Jun 29, 2026 FDA drug enforcement ### [Cinacalcet Hydrochloride Tablets, 90 mg, 30-count bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga, India; Manufactured for: Cipla USA, Inc., 10 Independence Boule...](https://isitonrecall.com/recall/fda-drug-d-0676-2026-cinacalcet-hydrochloride-tablets-90-mg-30-count-bottle-rx-only-manufactured-by-cipla-ltd-midc-patalg/) cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI). Class II Reported ongoing Distribution: USA Nationwide [Official source for Cinacalcet Hydrochloride Tablets, 90 mg, 30-count bottle, Rx Only, Manufactured by: Cipla Ltd., M...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0676-2026%22) Mar 16, 2026 FDA drug enforcement ### [Cinacalcet Hydrochloride Tablets, 30 mg, 30 Tablets per bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga, India; Manufactured for: Cipla USA, Inc., 10 Independence...](https://isitonrecall.com/recall/fda-drug-d-0449-2026-cinacalcet-hydrochloride-tablets-30-mg-30-tablets-per-bottle-rx-only-manufactured-by-cipla-ltd-midc/) CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit Class II Reported ongoing Distribution: Nationwide in the USA [Official source for Cinacalcet Hydrochloride Tablets, 30 mg, 30 Tablets per bottle, Rx Only, Manufactured by: Cipla L...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0449-2026%22) Mar 16, 2026 FDA drug enforcement ### [Cinacalcet Hydrochloride Tablets, 60 mg, 30 Tablets per bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga, India; Manufactured for: Cipla USA, Inc., 10 Independence...](https://isitonrecall.com/recall/fda-drug-d-0450-2026-cinacalcet-hydrochloride-tablets-60-mg-30-tablets-per-bottle-rx-only-manufactured-by-cipla-ltd-midc/) CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit Class II Reported ongoing Distribution: Nationwide in the USA [Official source for Cinacalcet Hydrochloride Tablets, 60 mg, 30 Tablets per bottle, Rx Only, Manufactured by: Cipla L...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0450-2026%22) Mar 16, 2026 FDA drug enforcement ### [Cinacalcet Hydrochloride Tablets, 90 mg, 30 Tablets per bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga, India; Manufactured for: Cipla USA, Inc., 10 Independence...](https://isitonrecall.com/recall/fda-drug-d-0451-2026-cinacalcet-hydrochloride-tablets-90-mg-30-tablets-per-bottle-rx-only-manufactured-by-cipla-ltd-midc/) CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit Class II Reported ongoing Distribution: Nationwide in the USA [Official source for Cinacalcet Hydrochloride Tablets, 90 mg, 30 Tablets per bottle, Rx Only, Manufactured by: Cipla L...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0451-2026%22) Mar 13, 2026 FDA drug enforcement ### [Lanreotide Injection, 120 mg\*/0.5 mL, Box contains 1 Pre-filled syringe and 1 safety needle, Single dose only, Rx Only, Manufactured by: Pharmathen International, S.A., Rodopi, ...](https://isitonrecall.com/recall/fda-drug-d-0422-2026-lanreotide-injection-120-mg-0-5-ml-box-contains-1-pre-filled-syringe-and-1-safety-needle-single-dose/) Lack of Assurance of Sterility: Due to an FDA observation at the contract manufacturing site for deficiencies in their visual inspection procedure. Class II Reported ongoing Distribution: Nationwide in the USA [Official source for Lanreotide Injection, 120 mg\*/0.5 mL, Box contains 1 Pre-filled syringe and 1 safety needle, Sing...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0422-2026%22) Mar 13, 2026 FDA drug enforcement ### [Lanreotide Injection, 120 mg/0.5 mL, Box contains 1 Pre-filled syringe, Single dose only, Rx Only, Manufactured by: Pharmathen International, S.A., Rodopi, Greece. Manufactured ...](https://isitonrecall.com/recall/fda-drug-d-0423-2026-lanreotide-injection-120-mg-0-5-ml-box-contains-1-pre-filled-syringe-single-dose-only-rx-only-manufa/) Lack of Assurance of Sterility: Due to an FDA observation at the contract manufacturing site for deficiencies in their visual inspection procedure. Class II Reported ongoing Distribution: Nationwide in the USA [Official source for Lanreotide Injection, 120 mg/0.5 mL, Box contains 1 Pre-filled syringe, Single dose only, Rx Only...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0423-2026%22) Feb 18, 2026 FDA drug enforcement ### [Nilotinib Capsules, 150 mg per capsule, packaged in cartons, Rx only, Manufactured by: Cipla Ltd., Verna, Goa, India, Manufactured for: Cipla USA, Inc., 10 Independence Boulevar...](https://isitonrecall.com/recall/fda-drug-d-0381-2026-nilotinib-capsules-150-mg-per-capsule-packaged-in-cartons-rx-only-manufactured-by-cipla-ltd-verna-go/) Failed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condition for Description test and Appearance by Visual Inspection test. Class III Reported ongoing Distribution: U.S.A. Nationwide [Official source for Nilotinib Capsules, 150 mg per capsule, packaged in cartons, Rx only, Manufactured by: Cipla Ltd....](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0381-2026%22) Feb 18, 2026 FDA drug enforcement ### [Nilotinib Capsules, 200 mg per capsule, packaged in cartons, Rx only, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059, Outer carton: 11...](https://isitonrecall.com/recall/fda-drug-d-0382-2026-nilotinib-capsules-200-mg-per-capsule-packaged-in-cartons-rx-only-manufactured-for-cipla-usa-inc-10/) Failed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condition for Description test and Appearance by Visual Inspection test. Class III Reported ongoing Distribution: U.S.A. Nationwide [Official source for Nilotinib Capsules, 200 mg per capsule, packaged in cartons, Rx only, Manufactured for: Cipla USA...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0382-2026%22) Jan 2, 2026 FDA drug enforcement ### [Lanreotide Injection, 120 mg/0.5 mL, 0.5 mL per pre-filled syringe, For deep subcutaneous injection, Rx Only, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite...](https://isitonrecall.com/recall/fda-drug-d-0290-2026-lanreotide-injection-120-mg-0-5-ml-0-5-ml-per-pre-filled-syringe-for-deep-subcutaneous-injection-rx/) Presence of Particulate Matter. Class II Reported ongoing Distribution: Nationwide in the USA [Official source for Lanreotide Injection, 120 mg/0.5 mL, 0.5 mL per pre-filled syringe, For deep subcutaneous injecti...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0290-2026%22) Dec 22, 2025 FDA drug enforcement ### [Diclofenac Sodium Topical Gel, 1%, NET WT 100 g (3.53 oz), Manufactured by: DPT Laboratories, Ltd., 307 E Josephine Street, San Antonio, TX 78215. NDC: 76282-103-39](https://isitonrecall.com/recall/fda-drug-d-0291-2026-diclofenac-sodium-topical-gel-1-net-wt-100-g-3-53-oz-manufactured-by-dpt-laboratories-ltd-307-e-jose/) Failed PH Specifications Class III Reported ongoing Distribution: Nationwide in the USA [Official source for Diclofenac Sodium Topical Gel, 1%, NET WT 100 g (3.53 oz), Manufactured by: DPT Laboratories, Ltd...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0291-2026%22) Nov 14, 2025 FDA drug enforcement ### [Cinacalcet Hydrochloride Tablets, 30 mg, 30 Tablets per bottle, Rx Only, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC: 69097-41...](https://isitonrecall.com/recall/fda-drug-d-0224-2026-cinacalcet-hydrochloride-tablets-30-mg-30-tablets-per-bottle-rx-only-manufactured-for-cipla-usa-inc/) CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits. Class II Reported ongoing Distribution: Nationwide in the US [Official source for Cinacalcet Hydrochloride Tablets, 30 mg, 30 Tablets per bottle, Rx Only, Manufactured for: Cipla ...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0224-2026%22) Nov 14, 2025 FDA drug enforcement ### [Cinacalcet Hydrochloride Tablets, 60 mg, 30 Tablets per bottle, Rx Only, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC: 69097-41...](https://isitonrecall.com/recall/fda-drug-d-0225-2026-cinacalcet-hydrochloride-tablets-60-mg-30-tablets-per-bottle-rx-only-manufactured-for-cipla-usa-inc/) CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits. Class II Reported ongoing Distribution: Nationwide in the US [Official source for Cinacalcet Hydrochloride Tablets, 60 mg, 30 Tablets per bottle, Rx Only, Manufactured for: Cipla ...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0225-2026%22) Nov 14, 2025 FDA drug enforcement ### [Cinacalcet Hydrochloride Tablets, 90 mg, 30 Tablets per bottle, Rx Only, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC: 69097-41...](https://isitonrecall.com/recall/fda-drug-d-0226-2026-cinacalcet-hydrochloride-tablets-90-mg-30-tablets-per-bottle-rx-only-manufactured-for-cipla-usa-inc/) CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits. Class II Reported ongoing Distribution: Nationwide in the US [Official source for Cinacalcet Hydrochloride Tablets, 90 mg, 30 Tablets per bottle, Rx Only, Manufactured for: Cipla ...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0226-2026%22) Oct 24, 2025 FDA drug enforcement ### [Lanthanum Carbonate chewable tablets, 1000mg\*, 10x9 bottles per patient pack carton, Rx Only, Manufactured by: Invagen Pharmaceuticals, Inc., Hauppauge, NY 11786, Manufactured f...](https://isitonrecall.com/recall/fda-drug-d-0217-2026-lanthanum-carbonate-chewable-tablets-1000mg-10x9-bottles-per-patient-pack-carton-rx-only-manufacture/) Failed stability specifications: Out of specification for hardness test Class II Reported ongoing Distribution: Nationwide in the USA [Official source for Lanthanum Carbonate chewable tablets, 1000mg\*, 10x9 bottles per patient pack carton, Rx Only, Man...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0217-2026%22) Oct 24, 2025 FDA drug enforcement ### [Lanthanum Carbonate chewable tablets, 1000mg\*, 10x9 bottles per patient pack carton, Rx Only, Manufactured by: Invagen Pharmaceuticals, Inc., (a subsidary of Cipla Ltd) Hauppaug...](https://isitonrecall.com/recall/fda-drug-d-0218-2026-lanthanum-carbonate-chewable-tablets-1000mg-10x9-bottles-per-patient-pack-carton-rx-only-manufacture/) Failed stability specifications: Out of specification for hardness test Class II Reported ongoing Distribution: Nationwide in the USA [Official source for Lanthanum Carbonate chewable tablets, 1000mg\*, 10x9 bottles per patient pack carton, Rx Only, Man...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0218-2026%22) Jul 24, 2025 FDA drug enforcement ### [Albuterol Sulfate, Inhalation Aerosol, 90 mcg, 200 metered Inhalations, NET CONTENT 6.7 g, Manufactured by: Cipla Ltd, Indore, SEZ, Pithampur, India; Manufactured for: Cipla USA...](https://isitonrecall.com/recall/fda-drug-d-0593-2025-albuterol-sulfate-inhalation-aerosol-90-mcg-200-metered-inhalations-net-content-6-7-g-manufactured-b/) 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. Class III Reported ongoing Distribution: U.S. Nationwide. [Official source for Albuterol Sulfate, Inhalation Aerosol, 90 mcg, 200 metered Inhalations, NET CONTENT 6.7 g, Manufa...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0593-2025%22) Jun 30, 2025 FDA drug enforcement ### [Budesonide Inhalation Suspension, 0.5mg/2ml, 30 single-dose ampules per carton, five per pouch, RX Only, Manufactured by: Cipla Ltd. Indore SEZ, Pithampur, India. Manufactured f...](https://isitonrecall.com/recall/fda-drug-d-0541-2025-budesonide-inhalation-suspension-0-5mg-2ml-30-single-dose-ampules-per-carton-five-per-pouch-rx-only/) Lack of Assurance of Sterility: A market complaint was received for leakage and empty ampoule. Class II Reported ongoing Distribution: Distributed Nationwide in the USA [Official source for Budesonide Inhalation Suspension, 0.5mg/2ml, 30 single-dose ampules per carton, five per pouch, R...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0541-2025%22) Oct 23, 2024 FDA drug enforcement ### [Lanthanum Carbonate Chewable Tablets, 1000mg, 10-count bottle, Rx only, Manufactured for Cipla USA, NDC 69097-0936-98](https://isitonrecall.com/recall/fda-drug-d-0043-2025-lanthanum-carbonate-chewable-tablets-1000mg-10-count-bottle-rx-only-manufactured-for-cipla-usa-ndc-6/) Failed Tablet/Capsule Specifications: Complaints received of crushed and broken tablets. Class II Reported ongoing Distribution: USA nationwide. [Official source for Lanthanum Carbonate Chewable Tablets, 1000mg, 10-count bottle, Rx only, Manufactured for Cipla US...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0043-2025%22) ## Reasons in these listed records - cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI). - CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit - Lack of Assurance of Sterility: Due to an FDA observation at the contract manufacturing site for deficiencies in their visual inspection procedure. - Failed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condition for Description test and Appearance by Visual Inspection test. These examples come from this result page and are not a ranking of every recall reason. ## Checking Cipla USA, Inc. ### Is there a recall on cipla usa, inc. right now? This archive contains 23 records, including 21 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product. ### How do I check my package or product? Compare the product, firm and lot, date, model or serial identifiers with the notice. [Use the label-check guide](https://isitonrecall.com/guides/read-lot-codes/) if you need help locating an identifier. ### Does a matching name mean every item is included? A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall. ### What if the search finds no matching record? This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. [Check source coverage](https://isitonrecall.com/sources/) and the agency's current notices. ### Where can I find older records? Use [monthly archives](https://isitonrecall.com/archives/) or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page. ## Keep checking [Search Cipla USA, Inc.](https://isitonrecall.com/check/?q=Cipla%20USA%2C%20Inc.) [Browse related products](https://isitonrecall.com/products/) [Review source dates](https://isitonrecall.com/sources/)