Cipla Cinacalcet Tablets Recalled for Nitrosamine Impurity Above Acceptable Limits
Key Takeaways
- The US Food and Drug Administration (FDA) is monitoring a voluntary, firm-initiated Class II recall of cinacalcet hydrochloride tablets (30 mg, 60 mg, 90 mg), involving over 272 000 bottles distributed nationwide with expiration dates from March 2026 through April 2027.
- The recall was initiated by Cipla USA, Inc. due to the presence of N-nitroso cinacalcet, a nitrosamine impurity above the acceptable daily intake limit.
- Cinacalcet is a calcimimetic agent indicated for the treatment of secondary hyperparathyroidism in patients with chronic kidney disease on dialysis, as well as hypercalcemia in parathyroid carcinoma.
The FDA has classified a Class II recall for multiple strengths of cinacalcet hydrochloride tablets—30 mg (NDC 69097-410-02), 60 mg (NDC 69097-411-02), and 90 mg (NDC 69097-412-02)—manufactured by Cipla Ltd. in India and distributed by Cipla USA, Inc., Warren, NJ. The recall affects a combined total of over 272 000 bottles distributed nationwide in the US, across multiple lot numbers with expiration dates ranging from March 2026 through April 2027. The recall was initiated on March 16, 2026.
The recall was prompted by current Good Manufacturing Practice (cGMP) deviations, specifically the detection of N-nitroso cinacalcet, a nitrosamine impurity, at levels exceeding the acceptable daily intake limit. Nitrosamines are classified as probable human carcinogens, raising concerns with prolonged exposure. The FDA classified the recall as Class II on April 10, 2026, indicating that use of the affected product may cause temporary or medically reversible adverse health consequences, with a low likelihood of serious harm. Cipla notified consignees via letter; no public press release has been issued.
Cinacalcet is a calcimimetic agent used to lower parathyroid hormone (PTH) levels in patients with secondary hyperparathyroidism undergoing dialysis, and to treat hypercalcemia associated with parathyroid carcinoma. Given its chronic use in renal patients, consistent drug quality is critical. Pharmacists should identify and quarantine affected lot numbers, ensure removal from inventory, and coordinate with prescribers to provide alternative supply.
Reference
FDA. Enforcement Report. April 15, 2026. Accessed April 16, 2026. https://www.accessdata.fda.gov/scripts/ires/index.cfm
