Cipla USA, Inc. Recalls

All product recalls associated with Cipla USA, Inc..

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Recall Summary

Total Recalls

9

Past Year

7

Class I (Serious)

0

Most Recent

Nov 2025

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 1–9 of 9 recalls

Cinacalcet Tablets 30mg (Cipla) – Nitrosamine Impurity (2025)

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

Class II

FDANov 14, 2025Nationwide• Cipla USA, Inc.

Cinacalcet Tablets 60mg (Cipla) – Nitrosamine Impurity (2025)

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

Class II

FDANov 14, 2025Nationwide• Cipla USA, Inc.

Cinacalcet Tablets 90mg (Cipla) – Nitrosamine Impurity (2025)

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

Class II

FDANov 14, 2025Nationwide• Cipla USA, Inc.

Lanthanum Carbonate Tablets (Cipla) - Stability Failure (2025)

Failed stability specifications: Out of specification for hardness test

Class II

FDAOct 24, 2025Nationwide• Cipla USA, Inc.

Lanthanum Carbonate Tablets (Cipla) - Stability Failure (2025)

Failed stability specifications: Out of specification for hardness test

Class II

FDAOct 24, 2025Nationwide• Cipla USA, Inc.

Albuterol Sulfate Inhaler (Cipla) – Particle Size Failure (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 III

FDAJul 24, 2025Nationwide• Cipla USA, Inc.