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, expiry: Lot 4PB0109, exp 1/31/2026, Lot 5PB0172, 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 used to treat conditions related to elevated parathyroid hormone levels, often prescribed for patients with chronic kidney disease or hyperparathyroidism. Patients buy these tablets for their potential to manage calcium and phosphorus levels in the body effectively.
Why This Is Dangerous
The recall is due to the presence of N-nitroso-cinacalcet, a nitrosamine impurity, which exceeds acceptable levels. Nitrosamines can form during the manufacturing process and have been linked to cancer risk.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Consumers must stop using the product immediately due to the potential health risks associated with nitrosamine exposure. This may lead to inconvenience as patients seek alternatives or consult their healthcare providers.
Practical Guidance
How to identify if yours is affected
- Check the bottle for the lot numbers: 4PB0109 or 5PB0172.
- Verify the expiry dates: 1/31/2026 or 1/31/2027.
- If you have purchased Cinacalcet Hydrochloride Tablets, confirm your product matches the recalled lots.
Where to find product info
Lot numbers and expiration dates are typically printed on the label or the bottom of the bottle.
What timeline to expect
Expect a refund or replacement to be processed within 4-6 weeks after returning the product.
If the manufacturer is unresponsive
- Keep records of your communication with the company.
- Reach out again, or escalate your inquiry to a consumer protection agency.
How to prevent similar issues
- Always check for recalls before using prescription medications.
- Consult your physician about potential alternatives if a recall occurs.
Documentation advice
Document your purchase by keeping receipts and any correspondence with the manufacturer regarding the recall.
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Product Details
The recall involves Cinacalcet Hydrochloride Tablets, 30 mg, sold in bottles of 30 tablets. The affected lot numbers are 4PB0109 (expiry 1/31/2026) and 5PB0172 (expiry 1/31/2027). These tablets were distributed nationwide in the U.S.
Key Facts
- Recall date: November 14, 2025
- Quantity recalled: 63,504 bottles
- Affected lot numbers: 4PB0109, 5PB0172
- Health risk: Nitrosamine impurity
- Immediate action required
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Safety Guide
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