Class II · Moderate risk
Cinacalcet Tablets
CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
Is Cinacalcet recalled?
Yes — there is an active recall. 22 ongoing FDA recalls mention Cinacalcet (31 total). Check the affected lots below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Cinacalcet. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Cinacalcet recalls on record
none so far in 2026; 31 on record, newest first
Class II · Moderate risk
Cinacalcet Tablets
CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
Class II · Moderate risk
Cinacalcet Tablets 60mg
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Class II · Moderate risk
Cinacalcet HCI active pharmaceutical ingredient packaged in…
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Class II · Moderate risk
CINACALCET HCL Tablet
Labeling:Label Mixup; CINACALCET HCL Tablet, 60 mg may be potentially mislabeled as RANOLAZINE ER, Tablet, 500 mg, NDC 61958100301, Pedigree: W003741, EXP: 6/26/2014.
Class II · Moderate risk
CINACALCET HCL Tablet
Labeling:Label Mixup; CINACALCET HCL, Tablet, 30 mg may be potentially mislabeled as ACETAMINOPHEN, Chew Tablet, 80 mg, NDC 00536323307, Pedigree: W003113, EXP: 6/13/2014; FERROUS SULFATE, Tablet, 325 mg (65 mg Elemental Iron), NDC 00904759160, Pedigree: AD54553_1, EXP: 5/20/2014; OMEGA-3-ACID ETHYL ESTERS, Capsule, 1000 mg, NDC 00173078302, Pedigree: AD32757_40, EXP: 5/14/2014; COLCHICINE,
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