Nearly 100,000 bottles of a prescription medication commonly used to treat chronic kidney disease and related conditions are being recalled across the United States after regulators identified the presence of potentially carcinogenic impurities above acceptable safety limits.
According to multiple notices published this week by the U.S. Food and Drug Administration (FDA), a total of 91,824 bottles of cinacalcet hydrochloride tablets are affected by the recall. The action involves three different dosage strengths of the drug and follows the detection of a nitrosamine impurity known as N-nitroso-cinacalcet, which exceeded the FDA’s established acceptable daily intake thresholds.
Cinacalcet hydrochloride is widely prescribed to patients with chronic kidney disease who are undergoing dialysis, as well as individuals suffering from hypercalcemia or primary hyperparathyroidism. The medication works by lowering parathyroid hormone levels, thereby helping regulate calcium levels in the blood.
The recalled products were manufactured by Cipla USA, a New Jersey–based subsidiary of the global pharmaceutical company Cipla Ltd., which is headquartered in Mumbai, India. According to the FDA, Cipla USA initiated the recall voluntarily in November, though the agency formally classified the action earlier this month.
FDA Classifies Recall as Class II
On December 9, the FDA officially designated the recall as a Class II action. Under FDA guidelines, a Class II recall applies to products that may cause temporary or medically reversible adverse health consequences, or situations in which the likelihood of serious health consequences is considered remote.
While the presence of nitrosamines raises legitimate safety concerns, the FDA emphasized that the recall does not indicate an immediate or acute health emergency. Instead, the classification reflects the potential long-term risks associated with sustained exposure to elevated levels of these compounds.
“Nitrosamine impurities may increase the risk of cancer if people are exposed to them above acceptable levels and over long periods of time,” the FDA states. However, the agency also notes that individuals who take medications containing nitrosamines at or below the acceptable daily intake limits every day for 70 years are not expected to experience an increased cancer risk.
What Are Nitrosamines?
Nitrosamines are organic chemical compounds that have been identified as probable human carcinogens. They are commonly found in small amounts in various everyday sources, including food products, drinking water, tobacco smoke, and certain medications.
Over the past several years, nitrosamine contamination has prompted widespread recalls across the pharmaceutical industry, affecting drugs used to treat conditions such as high blood pressure, diabetes, heartburn, and smoking cessation. The FDA has since intensified its oversight and testing protocols to detect and mitigate nitrosamine risks in prescription medications.
In the case of cinacalcet hydrochloride, FDA testing determined that the impurity N-nitroso-cinacalcet exceeded acceptable intake levels, triggering the recall.
Patients Urged Not to Stop Medication Abruptly
Despite the recall, federal health officials strongly caution patients not to stop taking cinacalcet without medical guidance. Abrupt discontinuation of the medication could lead to dangerous imbalances in calcium levels, particularly for patients with kidney disease or parathyroid disorders.
“Patients taking prescription drugs that have possible nitrosamine impurities should not stop taking their medication,” the FDA advises. “They should speak to their health care provider if they want to discuss alternative treatment options.”
Healthcare providers are expected to work with affected patients to determine whether alternative medications are appropriate or whether continued use poses minimal risk compared to the benefits of ongoing treatment.
Details of the Recalled Products
The FDA notices outline three specific cinacalcet hydrochloride products involved in the recall, all packaged in bottles containing 30 tablets. The recalled strengths, lot numbers, and quantities are as follows:
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30-milligram tablets
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National Drug Code (NDC): 69097-410-02
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Lot numbers: 4PB0109 (expiration January 31, 2026) and 5PB0172 (expiration January 31, 2027)
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63,504 bottles affected
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60-milligram tablets
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NDC: 69097-411-02
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Lot number: 5PB0164 (expiration January 31, 2027)
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15,744 bottles affected
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90-milligram tablets
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NDC: 69097-412-02
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Lot number: 5PB0183 (expiration January 31, 2027)
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12,576 bottles affected
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According to the FDA, the recall remains ongoing, and patients, pharmacies, and healthcare providers are encouraged to review inventory and treatment plans accordingly.
No Public Statement Issued by Manufacturer
As of this week, Cipla USA has not issued a public press release addressing the recall. The FDA notices confirm that the action was initiated voluntarily by the company, but further details regarding how the impurity was introduced or detected have not been disclosed publicly.
Cipla Ltd., the parent company, operates numerous manufacturing facilities worldwide and supplies medications to markets across North America, Europe, and Asia.
Prior FDA Warnings to Cipla
The recall comes amid prior regulatory scrutiny of Cipla’s manufacturing operations. In November 2023, the FDA issued a warning letter to Cipla Ltd. following inspections at one of its manufacturing plants in India. According to the agency, inspectors identified “significant violations” related to manufacturing practices.
The FDA also sent a separate warning letter to Cipla in 2020 after an inspection of another India-based facility uncovered compliance issues. While these prior actions were not directly linked to the cinacalcet recall, they highlight ongoing regulatory concerns regarding quality control and manufacturing standards.
The FDA has not stated whether the current recall is connected to any of the previously cited violations.
About Cinacalcet Hydrochloride
Cinacalcet hydrochloride is marketed under brand names such as Sensipar in the United States and Mimpara in other countries. It is commonly prescribed to patients with advanced kidney disease who experience secondary hyperparathyroidism, a condition in which the parathyroid glands release excessive hormone levels due to impaired kidney function.
The drug helps lower parathyroid hormone levels, reducing calcium buildup in the bloodstream and minimizing complications such as bone disease, cardiovascular issues, and calcification of soft tissues.
Given its critical role in managing serious chronic conditions, cinacalcet is often considered a long-term maintenance medication, making quality and safety concerns particularly significant.
What Patients Should Do Next
Patients who believe they may be taking one of the recalled cinacalcet products are advised to:
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Check the medication bottle for dosage strength, lot number, and expiration date
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Contact their pharmacist to confirm whether their prescription is affected
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Consult with their healthcare provider before making any changes to their medication regimen
Pharmacies are expected to coordinate with distributors and the manufacturer to remove recalled products from circulation and provide guidance to patients.
Ongoing Monitoring
The FDA stated that it will continue to monitor nitrosamine levels in pharmaceuticals and evaluate manufacturing practices to ensure patient safety. As recalls related to nitrosamine impurities continue to emerge across the drug industry, regulators have emphasized the importance of long-term surveillance and transparent reporting.
For now, federal officials stress that while the recall is serious, the risk to individual patients remains relatively low—particularly when weighed against the dangers of untreated chronic kidney disease and calcium imbalance.
As the recall process continues, healthcare providers and patients alike are urged to stay informed and consult medical professionals to ensure safe and effective treatment options remain in place.
Emily Johnson is a critically acclaimed essayist and novelist known for her thought-provoking works centered on feminism, women’s rights, and modern relationships. Born and raised in Portland, Oregon, Emily grew up with a deep love of books, often spending her afternoons at her local library. She went on to study literature and gender studies at UCLA, where she became deeply involved in activism and began publishing essays in campus journals. Her debut essay collection, Voices Unbound, struck a chord with readers nationwide for its fearless exploration of gender dynamics, identity, and the challenges faced by women in contemporary society. Emily later transitioned into fiction, writing novels that balance compelling storytelling with social commentary. Her protagonists are often strong, multidimensional women navigating love, ambition, and the struggles of everyday life, making her a favorite among readers who crave authentic, relatable narratives. Critics praise her ability to merge personal intimacy with universal themes. Off the page, Emily is an advocate for women in publishing, leading workshops that encourage young female writers to embrace their voices. She lives in Seattle with her partner and two rescue cats, where she continues to write, teach, and inspire a new generation of storytellers.
