The Recall Desk
HighFDA (Drugs)·D-0278-2025·Announced 2025-03-26

Cinacalcet Hydrochloride Tablets Recalled for Nitrosamine Impurity

Slate Run Pharmaceuticals is recalling Cinacalcet Hydrochloride Tablets 30 mg due to nitrosamine impurity above acceptable daily intake limits. 56,790 bottles were distributed to 8 wholesalers 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: This recall is classified as High because it involves a Class II FDA recall of a prescription medication containing nitrosamine, a high-risk substance, above acceptable daily intake limits. No illnesses or injuries have been reported.

Plain-English summary

Slate Run Pharmaceuticals is recalling Cinacalcet Hydrochloride Tablets 30 mg, 30-count bottles, distributed by Slate Run Pharma., LLC (Columbus, Ohio) and manufactured by Piramal Pharma Limited (Madhya Pradesh, India). The recall affects lot numbers 07711 (expires 07/2025), 08900 (expires 09/2026), and 08899 (expires 09/2026), totaling 56,790 bottles.

The recall was issued due to a Current Good Manufacturing Practice (CGMP) deviation: tablets contain nitrosamine impurity above acceptable daily intake limits. Nitrosamines are substances of concern due to potential health risks with continued exposure.

The affected tablets were distributed to 8 wholesalers and may have been distributed further nationwide. Patients currently taking this medication should contact their healthcare provider or pharmacist regarding the recall.

The recalled product

Product
Cinacalcet Hydrochloride Tablets 30 mg, 30-count bottle, Rx only, Distr. by: Slate Run Pharma., LLC, Columbus, Ohio 43215, Mfg. by: Piramal Pharma Limited, Madhya Pradesh, India, NDC 70436-007-04
Manufacturer
Slate Run Pharmaceuticals
Category
Drug
Hazard
Affected units
56,790

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 (5)

  • Lot # 07711
  • Exp 07/2025
  • 08900
  • Exp 09/2026
  • 08899

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

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Same hazard · nitrosamine

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