Cipla USA Inc. Recalls

Cinacalcet Hydrochloride Tablets, 30 mg, 30 Tablets per bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga, India; Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300,...

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

Cinacalcet Hydrochloride Tablets, 90 mg, 30 Tablets per bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga, India; Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300,...

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

Cinacalcet Hydrochloride Tablets, 60 mg, 30 Tablets per bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga, India; Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300,...

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

Cipla USA Lanreotide Injection Recall for Sterility Assurance Issue (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 lanreotide acetate pre-filled syringes recalled for sterility

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

Cipla Lanreotide Acetate Injection Recall: 15,221 Syringes Over Particulate Matter (2026)

Cipla USA Recalls Cinacalcet Hydrochloride Tablets Over Impurity Risk

CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.

Cipla USA Recalls Cinacalcet Hydrochloride Tablets Over Nitrosamine Hazard

CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.

Cipla Recalls Cinacalcet Hydrochloride Tablets Over Impurity Risk

CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.

Cipla Recalls Phytonadione Injectable Emulsion Due to Stability Issues

Failed Stability Specifications: Observed OOS results: eg results for colour index

Cipla USA Recalls Lanthanum Carbonate Tablets Over Stability Issues

Cipla USA recalled 1,180 boxes of Lanthanum Carbonate chewable tablets on October 24, 2025. The recall follows a failure to meet stability specifications for hardness tests. Consumers and healthcare providers must stop using the product immediately.

Cipla USA Albuterol Sulfate Inhalation Aerosol Recall Expanded for Stability Variance (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.