RecallCheckr

Cipla USA, Inc. recalls

9 recalls on record · FDA

Every recall we have on record for Cipla USA, Inc., compiled from federal safety data. Check the hazard, the remedy, and how serious each one is, and always confirm on the official notice.

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Health Serious

Cinacalcet Hydrochloride Tablets, 30 mg, 30 Tablets per bottle, Rx Only, Manufactured by:…

CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit

Cipla USA, Inc. Apr 22, 2026
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Health Serious

Cinacalcet Hydrochloride Tablets, 90 mg, 30 Tablets per bottle, Rx Only, Manufactured by:…

CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit

Cipla USA, Inc. Apr 22, 2026
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Health Serious

Lanreotide Injection, 120 mg/0.5 mL, Box contains 1 Pre-filled syringe, Single dose only,…

Lack of Assurance of Sterility: Due to an FDA observation at the contract manufacturing site for deficiencies in their visual inspection procedure.

Cipla USA, Inc. Apr 15, 2026
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Health Moderate

Nilotinib Capsules, 150 mg per capsule, packaged in cartons, Rx only, Manufactured by:…

Failed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condition for Description test and Appearance by Visual Inspection test.

Cipla USA, Inc. Mar 11, 2026
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Health Moderate

Diclofenac Sodium Topical Gel, 1%, NET WT 100 g (3.53 oz), Manufactured by: DPT…

Failed PH Specifications

Cipla USA, Inc. Jan 28, 2026
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Health Serious

Lanthanum Carbonate chewable tablets, 1000mg*, 10x9 bottles per patient pack carton, Rx…

Failed stability specifications: Out of specification for hardness test

Cipla USA, Inc. Dec 17, 2025
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Health Moderate

Albuterol Sulfate, Inhalation Aerosol, 90 mcg, 200 metered Inhalations, NET CONTENT 6.7…

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.

Cipla USA, Inc. Aug 27, 2025
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Health Serious

Budesonide Inhalation Suspension, 0.5mg/2ml, 30 single-dose ampules per carton, five per…

Lack of Assurance of Sterility: A market complaint was received for leakage and empty ampoule.

Cipla USA, Inc. Jul 30, 2025
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Health Serious

Ipratropium Bromide and Albuterol Sulfate Inhalation Solution USP, 0.5 mg & 3mg/3mL…

Short fill: Complaints received of less fill volume in respule and few drops of liquid observed in the intact pouch.

Cipla USA, Inc. May 1, 2024
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