DrugJul 8, 2026
Cinacalcet Hydrochloride Tablets, 30 mg, 30-count bottle recall — FDA D-0661-2026
cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).
Class IIFDA: OngoingCipla USA, Inc.
Recall history in this database
Classification mix: Class II: 14, Class III: 3.
DrugJul 8, 2026
Cinacalcet Hydrochloride Tablets, 90 mg, 30-count bottle recall — FDA D-0676-2026
cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).
Class IIFDA: OngoingCipla USA, Inc.
DrugJul 8, 2026
Cinacalcet Hydrochloride Tablets, 60 mg, 30-count bottle recall — FDA D-0675-2026
cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).
Class IIFDA: OngoingCipla USA, Inc.
DrugApr 22, 2026
Cinacalcet Hydrochloride Tablets, 30 mg, 30 Tablets per bottle recall — FDA D-0449-2026
CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit
Class IIFDA: OngoingCipla USA, Inc.
DrugApr 22, 2026
Cinacalcet Hydrochloride Tablets, 90 mg, 30 Tablets per bottle recall — FDA D-0451-2026
CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit
Class IIFDA: OngoingCipla USA, Inc.
DrugApr 22, 2026
Cinacalcet Hydrochloride Tablets, 60 mg, 30 Tablets per bottle recall — FDA D-0450-2026
CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit
Class IIFDA: OngoingCipla USA, Inc.
DrugApr 15, 2026
Lanreotide Injection, 120 mg/0.5 mL, Box contains 1 Pre-filled syringe, Single dose only recall — FDA D-0423-2026
Lack of Assurance of Sterility: Due to an FDA observation at the contract manufacturing site for deficiencies in their visual inspection procedure.
Class IIFDA: OngoingCipla USA, Inc.
DrugApr 15, 2026
Lanreotide Injection, 120 mg*/0.5 mL, Box contains 1 Pre-filled syringe and 1 safety needle recall — FDA D-0422-2026
Lack of Assurance of Sterility: Due to an FDA observation at the contract manufacturing site for deficiencies in their visual inspection procedure.
Class IIFDA: OngoingCipla USA, Inc.
DrugMar 11, 2026
Nilotinib Capsules, 150 mg per capsule recall — FDA D-0381-2026
Failed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condition for Description test and Appearance by Visual Inspection test.
Class IIIFDA: OngoingCipla USA, Inc.
DrugMar 11, 2026
Nilotinib Capsules, 200 mg per capsule recall — FDA D-0382-2026
Failed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condition for Description test and Appearance by Visual Inspection test.
Class IIIFDA: OngoingCipla USA, Inc.
DrugDec 17, 2025
Lanthanum Carbonate chewable tablets, 1000mg*, 10x9 bottles per patient pack carton recall — FDA D-0217-2026
Failed stability specifications: Out of specification for hardness test
Class IIFDA: OngoingCipla USA, Inc.
DrugDec 17, 2025
Cinacalcet Hydrochloride Tablets, 90 mg, 30 Tablets per bottle recall — FDA D-0226-2026
CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
Class IIFDA: OngoingCipla USA, Inc.
DrugDec 17, 2025
Cinacalcet Hydrochloride Tablets, 30 mg, 30 Tablets per bottle recall — FDA D-0224-2026
CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
Class IIFDA: OngoingCipla USA, Inc.
DrugDec 17, 2025
Lanthanum Carbonate chewable tablets, 1000mg*, 10x9 bottles per patient pack carton recall — FDA D-0218-2026
Failed stability specifications: Out of specification for hardness test
Class IIFDA: OngoingCipla USA, Inc.
DrugDec 17, 2025
Cinacalcet Hydrochloride Tablets, 60 mg, 30 Tablets per bottle recall — FDA D-0225-2026
CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
Class IIFDA: OngoingCipla USA, Inc.
DrugAug 27, 2025
Albuterol Sulfate, Inhalation Aerosol, 90 mcg, 200 metered Inhalations, NET CONTENT 6.7 g recall — FDA D-0593-2025
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 IIIFDA: OngoingCipla USA, Inc.
DrugJul 30, 2025
Budesonide Inhalation Suspension, 0.5mg/2ml, 30 single-dose ampules per carton, five per recall — FDA D-0541-2025
Lack of Assurance of Sterility: A market complaint was received for leakage and empty ampoule.
Class IIFDA: OngoingCipla USA, Inc.
Understanding this recall history
This page summarizes recall records in which the official source identifies Cipla USA, Inc. as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.