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 5PB0183, 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 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.
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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.
Key Facts
- Recall date: November 14, 2025
- Quantity recalled: 12,576 bottles
- Health risk due to nitrosamine impurity
- Contact healthcare providers for guidance
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Safety Guide
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