Cinacalcet Tablets Recalled for cGMP Deviations
Cipla USA, Inc. is recalling Cinacalcet Hydrochloride Tablets, 60 mg due to cGMP deviations involving the presence of N-nitroso-cinacalcet above acceptable daily intake levels.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class II recall involving a prescription drug with a potential safety concern (N-nitroso impurity above acceptable intake levels). Class II recalls with pharmaceutical safety hazards warrant a Severe classification per the rubric.
Plain-English summary
Cipla USA, Inc. is recalling Cinacalcet Hydrochloride Tablets, 60 mg (30-count bottles, NDC 69097-411-02) distributed nationwide. The recall is due to cGMP deviations: the presence of N-nitroso-cinacalcet in the product at levels above the acceptable daily intake (ADI).
The affected lots are 5PB0165 and 5PB0166 (expiration 1/31/2027); 5PB0552 (expiration 4/30/2027); and 5PB0642, 5PB0643, and 5PB0644 (expiration 6/30/2027). Cinacalcet is a prescription medication used to treat hyperparathyroidism.
Consumers who have this medication should contact their healthcare provider or pharmacist for guidance. Do not discontinue use of the medication without consulting a healthcare professional.
The recalled product
- Product
- CINACALCET (CINACALCET)
- Brand
- CINACALCET
- Manufacturer
- Cipla USA, Inc.
- Hazard
- n-nitroso-impurity
- cGMP-deviation
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (9)
- Lot #: 5PB0165
- 5PB0166
- Exp 1/31/2027
- 5PB0552
- Exp 4/30/2027
- 5PB0642
- 5PB0643
- 5PB0644
- Exp 6/30/2027
Distribution
Distributed nationwide across the United States.
Related recalls
Same brand · CINACALCET
- SevereCinacalcet Hydrochloride Tablets Recalled for Elevated Impurity Levels
FDA (Drugs) · 2026-07-08
- HighCinacalcet Tablets Recalled for N-Nitroso Impurity Exceeding Limits
FDA (Drugs) · 2026-07-08
- HighCinacalcet Tablets Recalled for N-Nitroso Impurity Exceeding FDA Safety Limit
FDA (Drugs) · 2024-12-11
- HighFDA Recalls Cinacalcet 30mg Tablets for N-nitroso Impurity
FDA (Drugs) · 2024-12-11
- HighPrescription Cinacalcet Tablets Recalled for N-Nitroso Impurity
FDA (Drugs) · 2024-12-11
Same category
- CriticalWarfarin Tablets Recalled After Mix-Up Between 2.5 mg and 5 mg Strengths
FDA (Drugs) · 2026-07-21
- SevereChloraPrep One-Step Antiseptic Applicators recalled for lack of sterility assurance
FDA (Drugs) · 2026-07-08
- SevereAccucaine Lidocaine Injection Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2026-07-08
- SevereChloraPrep One-Step Sterile Solution Lacks Assurance of Sterility
FDA (Drugs) · 2026-07-08
- ModerateMedline Convenience Kits Block Tray recalled due to quality defects
FDA (Devices) · 2026-07-08