Cinacalcet Hydrochloride Tablets Recalled for Nitrosamine Impurity Above Safe Limits
Slate Run Pharmaceuticals is recalling Cinacalcet Hydrochloride Tablets 60 mg for containing nitrosamine impurity above acceptable daily intake limits. The recall affects 2,444 bottles distributed nationwide.
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: FDA Class II recall involving nitrosamine impurity exceeding acceptable daily intake limits. While no illnesses or injuries have been reported, nitrosamines are potentially carcinogenic compounds, representing a risk-of-harm situation with significant potential health consequences.
Plain-English summary
Slate Run Pharmaceuticals is recalling Cinacalcet Hydrochloride Tablets 60 mg (NDC 70436-008-04) due to manufacturing deviations identified during quality control. Testing revealed the presence of nitrosamine impurity at levels exceeding FDA-acceptable daily intake limits. Nitrosamines are potentially carcinogenic compounds.
The affected product is Lot #109797 with an expiration date of November 2026, comprising 2,444 bottles in 30-count packages. The product was distributed to 8 wholesalers who may have further distributed it nationwide. The drug is manufactured by Piramal Pharma Limited in Madhya Pradesh, India, and distributed by Slate Run Pharmaceuticals, LLC in Columbus, Ohio.
Patients currently taking Cinacalcet Hydrochloride from this lot should contact their healthcare provider to discuss the recall and appropriate next steps. Do not stop taking any prescription medication without consulting your doctor. Return unused medication to your pharmacy for proper disposal.
The recalled product
- Product
- Cinacalcet Hydrochloride Tablets 60 mg, 30-count bottle, Rx only, Distr. by: Slate Run Pharma., LLC, Columbus, Ohio 43215, Mfg. by: Piramal Pharma Limited, Madhya Pradesh, India, NDC 70436-008-04
- Manufacturer
- Slate Run Pharmaceuticals
- Category
- Drug — Prescription Drug
- Hazard
- nitrosamine
- contamination
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 (2)
- Lot # 109797
- Exp 11/2026
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
- ModerateFDA Recalls Pred Mild Ophthalmic Suspension Due to Failed Stability Specifications
FDA (Drugs) · 2026-06-03
- ModerateNicotine Transdermal System Patches Recalled for Oxidative Impurity Specification Failure
FDA (Drugs) · 2026-06-03
- HighLiraglutide Injection Recalled Due to Particulate Matter in Cartridges
FDA (Drugs) · 2026-05-27
- LowPrimidone Tablets Recalled for Cross-Contamination with Acemetacin
FDA (Drugs) · 2026-05-27