[pending] CINACALCET (CINACALCET)
Pending LLM rewrite. Source: FDA_DRUG D-0449-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit
The recalled product
- Product
- CINACALCET (CINACALCET)
- Brand
- CINACALCET
- Manufacturer
- Cipla USA, Inc.
- Category
- Drug — Drugs
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 (7)
- Lot
- expiry: Lot 4PB0526
- 4PB0527
- 4PB0528
- exp September-2026
- Lot 5PB0173
- exp January-2027
Distribution
Distributed nationwide across the United States.
Related recalls
Same brand · CINACALCET
- SevereCinacalcet Tablets Recalled for cGMP Deviations
FDA (Drugs) · 2026-07-08
- HighCinacalcet Tablets Recalled for N-Nitroso Impurity Exceeding Limits
FDA (Drugs) · 2026-07-08
- SevereCinacalcet Hydrochloride Tablets Recalled for Elevated Impurity Levels
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
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
- SevereChloraPrep One-Step Sterile Solution Lacks Assurance of Sterility
FDA (Drugs) · 2026-07-08
- SevereAccucaine Lidocaine Injection Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2026-07-08
- ModerateMedline Convenience Kits Block Tray recalled due to quality defects
FDA (Devices) · 2026-07-08