Cipla USA recalled 12,576 bottles of Cinacalcet Hydrochloride Tablets on November 14, 2025, due to a nitrosamine impurity. The impurity, N-nitroso-cinacalcet, exceeds acceptable daily intake limits. Consumers must stop using this product immediately and contact healthcare providers for guidance.
CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
Consumers and healthcare providers should stop using this product immediately. Contact Cipla USA, Inc. or your healthcare provider for guidance. Notification method: Letter
Get instant alerts for Health & Personal Care recalls
Be the first to know. Free instant alerts to your inbox.
Cinacalcet Hydrochloride Tablets are used to treat conditions related to parathyroid hormone regulation. Consumers typically buy this medication to manage calcium levels in patients with certain disorders.
The presence of N-nitroso-cinacalcet in the tablets poses a significant health risk as this impurity can lead to carcinogenic effects if consumed above safe levels.
This recall is not part of a broader industry pattern.
Consumers must discontinue use of the product immediately, which may affect their treatment plan and require alternative medications.
The lot number and expiration date can typically be found on the label of the bottle.
Expect a refund or replacement processing time of 4-6 weeks.
Keep records of your purchase, including receipts and any correspondence with the company regarding the recall.
The recall involves Cinacalcet Hydrochloride Tablets, 90 mg, sold in bottles of 30. The affected lot number is Lot 5PB0183, with an expiration date of January 31, 2027.
Not sure what to do next? Our guide walks you through the process step by step.
Read: What to Do When You Find a Recalled ProductGet instant alerts for recalls that affect you. Free forever.
Cipla USA, Inc. recalls lanreotide acetate 120 mg/0.5 mL pre-filled syringes distributed nationwide due to lack of assurance of sterility after FDA observations at the contract manufacturer. Health care providers and patients should stop use immediately and contact Cipla or their clinician for guidance.
Cipla USA Inc. recalls 54,583 Lanreotide acetate injections nationwide after FDA flagged sterility assurance concerns at a contract manufacturer. The recall covers a box containing one pre-filled syringe and one safety needle. Healthcare providers and patients should stop using the product immediately and follow the company’s guidance for disposal and refunds.
Cipla USA, Inc. is recalling 15,221 Lanreotide Acetate Injection syringes nationwide in the United States after detecting particulate matter. The defect is the presence of particulate matter in the injectable solution. Healthcare providers and patients should stop using the product immediately and contact Cipla USA for guidance.
Cipla USA, Inc. recalled 15,744 bottles of Cinacalcet Hydrochloride Tablets on November 14, 2025. The recall follows the discovery of a nitrosamine impurity exceeding acceptable daily intake limits. Consumers should stop using the product immediately and consult healthcare providers.
Cipla USA, Inc. recalled 63,504 bottles of Cinacalcet Hydrochloride Tablets on November 14, 2025. The recall results from a nitrosamine impurity, N-nitroso-cinacalcet, exceeding acceptable daily intake limits. Consumers should stop using the tablets immediately and contact healthcare providers for guidance.
Cipla USA recalled 4,438 cartons of Phytonadione Injectable Emulsion on October 31, 2025. The product failed stability specifications, raising concerns about its safety. Consumers and healthcare providers must stop using the product immediately and seek guidance.
Cipla USA recalled 1,180 boxes of Lanthanum Carbonate chewable tablets on October 24, 2025. The recall follows a failure to meet stability specifications for hardness tests. Consumers and healthcare providers must stop using the product immediately.
Cipla USA Inc. recalls 20,352 packs of Albuterol Sulfate Inhalation Aerosol after failing stability specifications. The defective lots were distributed nationwide in the United States. The issue involves out of specification results in particle size distribution at the 12-month time point. Patients and healthcare providers should stop use and contact Cipla USA for guidance.