[pending] CINACALCET (CINACALCET)
Pending LLM rewrite. Source: FDA_DRUG D-0451-2026.
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 (9)
- Lot
- expiry: 4PB0224
- exp March-2026
- 4PB0505
- 4PB0506
- 4PB0507
- exp September-2026
- 5PB0564
- exp April-2027
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- CriticalWarfarin Tablets Recalled After Mix-Up Between 2.5 mg and 5 mg Strengths
FDA (Drugs) · 2026-07-21
- SevereAtomoxetine Capsules Recalled Due to Labeling Mix-Up Error
FDA (Drugs) · 2026-05-27
- LowBusulfan Injection Recalled for Failed Impurities and Degradation Specifications
FDA (Drugs) · 2026-05-27
- SevereMG217 Multi-Symptom Treatment Cream recalled for microbial contamination
FDA (Drugs) · 2026-05-27
- LowPrimidone Tablets Recalled for Cross-Contamination with Acemetacin
FDA (Drugs) · 2026-05-27