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
- Affected units
- 2,444
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.
Part of a larger recall action
This product is one of 2 recalled by Slate Run Pharmaceuticals under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · Slate Run Pharmaceuticals
See all →- LowEptifibatide Injection Labeling Error Recall by Slate Run
FDA (Drugs) · 2026-03-04
- HighCinacalcet Hydrochloride Tablets Recalled for Nitrosamine Impurity
FDA (Drugs) · 2025-03-26
Same hazard · nitrosamine
See all →- SevereFDA Recalls Mirabegron Tablets Over Nitrosamine Impurity
FDA (Drugs) · 2026-08-12
- HighDuloxetine 30mg delayed-release capsules exceed nitrosamine impurity interim limit
FDA (Drugs) · 2026-06-17
- HighDuloxetine 60mg delayed-release capsules exceed nitrosamine impurity interim limit
FDA (Drugs) · 2026-06-17
- ModerateBisoprolol and hydrochlorothiazide tablets recalled over a nitrosamine impurity
FDA (Drugs) · 2026-02-11
- HighClomipramine 25 mg capsules recalled over nitrosamine above the intake limit
FDA (Drugs) · 2025-11-12