Cipla recalls
FDA enforcement reports naming CIPLA as the recalling firm.
- Recall reports
- 37
- Class I (serious)
- 1
- Most recent report
- Jul 8, 2026
- Jul 8, 2026Cinacalcet Hydrochloride Tablets, 90 mg, 30-count bottle, Rx Only, Manufactured by: Cip…Drug · Cipla USA, Inc.cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).Class II
- Jul 8, 2026Cinacalcet Hydrochloride Tablets, 60 mg, 30-count bottle, Rx Only, Manufactured by: Cip…Drug · Cipla USA, Inc.cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).Class II
- Jul 8, 2026Cinacalcet Hydrochloride Tablets, 30 mg, 30-count bottle, Rx Only, Manufactured by: Cip…Drug · Cipla USA, Inc.cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).Class II
- Apr 22, 2026Cinacalcet Hydrochloride Tablets, 60 mg, 30 Tablets per bottle, Rx Only, Manufactured b…Drug · Cipla USA, Inc.CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limitClass II
- Apr 22, 2026Cinacalcet Hydrochloride Tablets, 90 mg, 30 Tablets per bottle, Rx Only, Manufactured b…Drug · Cipla USA, Inc.CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limitClass II
- Apr 22, 2026Cinacalcet Hydrochloride Tablets, 30 mg, 30 Tablets per bottle, Rx Only, Manufactured b…Drug · Cipla USA, Inc.CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limitClass II
- Apr 15, 2026Lanreotide Injection, 120 mg/0Drug · Cipla USA, Inc.Lack of Assurance of Sterility: Due to an FDA observation at the contract manufacturing site for deficiencies in their visual inspection procedure.Class II
- Apr 15, 2026Lanreotide Injection, 120 mg*/0Drug · Cipla USA, Inc.Lack of Assurance of Sterility: Due to an FDA observation at the contract manufacturing site for deficiencies in their visual inspection procedure.Class II
- Mar 11, 2026Nilotinib Capsules, 200 mg per capsule, packaged in cartons, Rx only, Manufactured for:…Drug · Cipla USA, Inc.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
- Mar 11, 2026Nilotinib Capsules, 150 mg per capsule, packaged in cartons, Rx only, Manufactured by:…Drug · Cipla USA, Inc.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
- Diclofenac Sodium Topical Gel, 1%
- Lanreotide Injection, 120 mg/0
- Lanthanum Carbonate chewable tablets, 1000mg*, 10x9 bottles per patient pack carton, Rx…
- Cinacalcet Hydrochloride Tablets, 90 mg, 30 Tablets per bottle, Rx Only, Manufactured f…
- Cinacalcet Hydrochloride Tablets, 60 mg, 30 Tablets per bottle, Rx Only, Manufactured f…
- Cinacalcet Hydrochloride Tablets, 30 mg, 30 Tablets per bottle, Rx Only, Manufactured f…
- Lanthanum Carbonate chewable tablets, 1000mg*, 10x9 bottles per patient pack carton, Rx…
- Phytonadione Injectable Emulsion, USP 10mg/mL, 10x1 mL Single-Dose Vial/carton, Rx Only…
- Albuterol Sulfate, Inhalation Aerosol, 90 mcg, 200 metered Inhalations
- Budesonide Inhalation Suspension, 0
- Lanthanum Carbonate Chewable Tablets, 1000mg, 10-count bottle, Rx only, Manufactured fo…
- Lanthanum Carbonate Chewable Tablets, 1000mg, 10-count bottle, Rx only, Manufactured fo…
- Ipratropium Bromide and Albuterol Sulfate Inhalation Solution USP, 0
- Albuterol Sulfate Inhalation Aerosol, 90 mcg, 200 Metered Inhalation
- Arformoterol Tartrate Inhalation Solution, 15 mcg/2mL, 2 mL Sterile Unit-Dose Vial pack…
- Budesonide Inhalation Suspension 0
- Difluprednate Ophthalmic Emulsion, 0
- Difluprednate Ophthalmic Emulsion, 0
- Difluprednate Ophthalmic Emulsion 0
- Difluprednate Ophthalmic Emulsion, 0
- Solifenacin Succinate Tablets, 10 mg, 30-count bottles, Rx Only, Manufactured by: Cipla…
- Esomeprazole Magnesium for Delayed-Release Oral Suspension 40mg, packaged in unit dose…
- Esomeprazole Magnesium for Delayed-Release Oral Suspension 20mg, packaged in unit dose…
- Esomeprazole Magnesium for Delayed-Release Oral Suspension 10mg, packaged in unit dose…
- Azacitidine for Injection 100 mg/vial For Subcutaneous and Intravenous Use Only Single-…
- Nevirapine Extended Release Tablets, 400 mg, 30-count bottle, Rx Only, Manufactured by:…
- Levalbuterol Inhalation Solution, USP, 0
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