Cipla USA, Inc.
Complete recall history across all FDA and CPSC categories — 15 total recalls
Cipla USA, Inc. appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.
Drug Recalls (15)
FDA drug safety enforcement actions by Cipla USA, Inc.
| Date | Product | Reason | Class |
|---|---|---|---|
| Mar 16, 2026 | Cinacalcet Hydrochloride Tablets, 60 mg, 30 Tablets per bottle, Rx Only, Manu... | CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily int... | Class II |
| Mar 16, 2026 | Cinacalcet Hydrochloride Tablets, 90 mg, 30 Tablets per bottle, Rx Only, Manu... | CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily int... | Class II |
| Mar 16, 2026 | Cinacalcet Hydrochloride Tablets, 30 mg, 30 Tablets per bottle, Rx Only, Manu... | CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily int... | Class II |
| Mar 13, 2026 | Lanreotide Injection, 120 mg*/0.5 mL, Box contains 1 Pre-filled syringe and 1... | Lack of Assurance of Sterility: Due to an FDA observation at the contract man... | Class II |
| Mar 13, 2026 | Lanreotide Injection, 120 mg/0.5 mL, Box contains 1 Pre-filled syringe, Singl... | Lack of Assurance of Sterility: Due to an FDA observation at the contract man... | Class II |
| Feb 18, 2026 | Nilotinib Capsules, 200 mg per capsule, packaged in cartons, Rx only, Manufac... | Failed Tablet/Capsule Specifications: Observed OOS results at 6-months long-t... | Class III |
| Feb 18, 2026 | Nilotinib Capsules, 150 mg per capsule, packaged in cartons, Rx only, Manufac... | Failed Tablet/Capsule Specifications: Observed OOS results at 6-months long-t... | Class III |
| Jan 2, 2026 | Lanreotide Injection, 120 mg/0.5 mL, 0.5 mL per pre-filled syringe, For deep ... | Presence of Particulate Matter. | Class II |
| Dec 22, 2025 | Diclofenac Sodium Topical Gel, 1%, NET WT 100 g (3.53 oz), Manufactured by: D... | Failed PH Specifications | Class III |
| Nov 14, 2025 | Cinacalcet Hydrochloride Tablets, 60 mg, 30 Tablets per bottle, Rx Only, Manu... | CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet... | Class II |
| Nov 14, 2025 | Cinacalcet Hydrochloride Tablets, 30 mg, 30 Tablets per bottle, Rx Only, Manu... | CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet... | Class II |
| Nov 14, 2025 | Cinacalcet Hydrochloride Tablets, 90 mg, 30 Tablets per bottle, Rx Only, Manu... | CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet... | Class II |
| Oct 24, 2025 | Lanthanum Carbonate chewable tablets, 1000mg*, 10x9 bottles per patient pack ... | Failed stability specifications: Out of specification for hardness test | Class II |
| Oct 24, 2025 | Lanthanum Carbonate chewable tablets, 1000mg*, 10x9 bottles per patient pack ... | Failed stability specifications: Out of specification for hardness test | Class II |
| Jul 24, 2025 | Albuterol Sulfate, Inhalation Aerosol, 90 mcg, 200 metered Inhalations, NET C... | Failed Stability Specifications: Out of specification results was observed in... | Class III |
| Jun 30, 2025 | Budesonide Inhalation Suspension, 0.5mg/2ml, 30 single-dose ampules per carto... | Lack of Assurance of Sterility: A market complaint was received for leakage a... | Class II |
| Oct 23, 2024 | Lanthanum Carbonate Chewable Tablets, 1000mg, 10-count bottle, Rx only, Manuf... | Failed Tablet/Capsule Specifications: Complaints received of crushed and brok... | Class II |
| Oct 23, 2024 | Lanthanum Carbonate Chewable Tablets, 1000mg, 10-count bottle, Rx only, Manuf... | Failed Tablet/Capsule Specifications: Complaints received of crushed and brok... | Class II |
| Mar 26, 2024 | Ipratropium Bromide and Albuterol Sulfate Inhalation Solution USP, 0.5 mg & 3... | Short fill: Complaints received of less fill volume in respule and few drops ... | Class II |
| Jun 27, 2023 | Albuterol Sulfate Inhalation Aerosol, 90 mcg, 200 Metered Inhalation, net con... | Defective container: empty inhaler and leakage observed through the inhaler v... | Class I |
Frequently Asked Questions
A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.
Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.
The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.
Yes. You can search for any company using the firm/manufacturer pages for each category: Food Firms, Drug Firms, Device Firms, or Product Manufacturers. You can also use the search functionality on any browse page to find recalls by company name.
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