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
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Drug Safety; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- CINACALCET, Cipla USA Inc.
- Product type
- Cinacalcet Hydrochloride Tablets
- Model numbers
- Lot 5PB0164, exp 1/31/2027
- UPC codes
- 69097-410, 69097-411, 69097-412, 69097-410-02, 69097-411-02, 69097-412-02
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
November 14, 2025
Reported by FDA DRUG
December 17, 2025
RecallRadar source check
December 24, 2025
Consumer action
Use the official remedy and keep documentation.
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
About This Product
Cinacalcet Hydrochloride Tablets are prescribed for managing conditions related to parathyroid hormone levels, particularly in patients with chronic kidney disease. They help regulate calcium levels in the body, making them essential for certain patients.
Why This Is Dangerous
The presence of N-nitroso-cinacalcet in the tablets poses a health risk as it exceeds acceptable daily intake limits. This impurity can lead to serious health consequences if consumed regularly.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Consumers may face health risks associated with the impurity in the recalled tablets. The urgency to stop use and seek alternatives may lead to disruptions in treatment for some patients.
Practical Guidance
How to identify if yours is affected
- Locate the lot number on your bottle of Cinacalcet Hydrochloride Tablets.
- Check if it matches Lot 5PB0164.
- Confirm the expiration date is January 31, 2027.
Where to find product info
The lot number and expiration date can typically be found on the label or bottom of the bottle.
What timeline to expect
Expect a refund or further instructions within 4-6 weeks following the recall notification.
If the manufacturer is unresponsive
- Contact Cipla USA, Inc. directly via phone or email.
- Document all correspondence regarding the recall.
How to prevent similar issues
- Always check for recent recalls on medications before use.
- Consult your healthcare provider about alternatives if a recall occurs.
Documentation advice
Keep receipts, correspondence with the manufacturer, and any medical records related to your use of the affected product.
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Product Details
The recall involves Cinacalcet Hydrochloride Tablets, 60 mg, sold in 30-tablet bottles. The affected lot is Lot 5PB0164, which has an expiration date of January 31, 2027. The product was distributed nationwide in the United States.
Key Facts
- Recall date: November 14, 2025
- Quantity recalled: 15,744 bottles
- Affected lot: Lot 5PB0164
- Expiration date: January 31, 2027
- Hazard: Nitrosamine impurity present
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Safety Guide
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