Cipla USA, Inc. recalls
16 recalls.
- Fosfomycin Tromethamine Granules for Oral Solution recall (Cipla USA, Inc.)
DrugClass IIReported October 14, 2026 · Failed Impurities/Degradation Specifications - Cinacalcet Hydrochloride Tablets recall (Cipla USA, Inc.)
DrugClass IIReported July 8, 2026 · cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI). - Cinacalcet Hydrochloride Tablets recall (Cipla USA, Inc.)
DrugClass IIReported July 8, 2026 · cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI). - Cinacalcet Hydrochloride Tablets recall (Cipla USA, Inc.)
DrugClass IIReported July 8, 2026 · cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI). - Cinacalcet Hydrochloride Tablets recall (Cipla USA, Inc.)
DrugClass IIReported April 22, 2026 · CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit - Cinacalcet Hydrochloride Tablets recall (Cipla USA, Inc.)
DrugClass IIReported April 22, 2026 · CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit - Cinacalcet Hydrochloride Tablets recall (Cipla USA, Inc.)
DrugClass IIReported April 22, 2026 · CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit - Lanreotide Injection recall (Cipla USA, Inc.)
DrugClass IIReported April 15, 2026 · Lack of Assurance of Sterility: Due to an FDA observation at the contract manufacturing site for deficiencies in their visual inspection procedure. - Lanreotide Injection recall (Cipla USA, Inc.)
DrugClass IIReported April 15, 2026 · Lack of Assurance of Sterility: Due to an FDA observation at the contract manufacturing site for deficiencies in their visual inspection procedure. - Nilotinib Capsules recall (Cipla USA, Inc.)
DrugClass IIIReported March 11, 2026 · Failed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condition for Description test and Appearance by Visual Inspection... - Nilotinib Capsules recall (Cipla USA, Inc.)
DrugClass IIIReported March 11, 2026 · Failed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condition for Description test and Appearance by Visual Inspection... - Diclofenac Sodium Topical Gel recall (Cipla USA, Inc.)
DrugClass IIIReported January 28, 2026 · Failed PH Specifications - Lanreotide Injection recall (Cipla USA, Inc.)
DrugClass IIReported January 21, 2026 · Presence of Particulate Matter. - Cinacalcet Hydrochloride Tablets recall (Cipla USA, Inc.)
DrugClass IIReported December 17, 2025 · CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits. - Cinacalcet Hydrochloride Tablets recall (Cipla USA, Inc.)
DrugClass IIReported December 17, 2025 · CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits. - Cinacalcet Hydrochloride Tablets recall (Cipla USA, Inc.)
DrugClass IIReported December 17, 2025 · CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.