Cipla USA Recalls Cinacalcet Hydrochloride Tablets Over Impurity Risk
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.
Quick Facts at a Glance
Recall Date
November 14, 2025
Hazard Level
HIGH
Brands
CINACALCET, Cipla USA Inc.
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
1 states
At-Risk Groups
GENERAL
Hazard Information
CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
What You Should Do
Consumers and healthcare providers should stop using this product immediately. Contact Cipla USA, Inc. or your healthcare provider for guidance. Notification method: Letter
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About This Product
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.
Why This Is Dangerous
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.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Consumers must discontinue use of the product immediately, which may affect their treatment plan and require alternative medications.
Practical Guidance
How to identify if yours is affected
Check the bottle for the lot number; affected lot is Lot 5PB0183.
Verify the expiration date; affected products expire on January 31, 2027.
Consult your healthcare provider if you are unsure about the status of your product.
Where to find product info
The lot number and expiration date can typically be found on the label of the bottle.
What timeline to expect
Expect a refund or replacement processing time of 4-6 weeks.
If the manufacturer is unresponsive
Document all communications with the company.
Follow up with Cipla USA, Inc. if you do not receive a response within a reasonable time.
How to prevent similar issues
Always check for recalls on medications before use.
Consult with healthcare providers about alternative treatments if a recall is issued.
Documentation advice
Keep records of your purchase, including receipts and any correspondence with the company regarding the recall.
Product Details
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.
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