HIGH

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

  1. Check the bottle for the lot number; affected lot is Lot 5PB0183.
  2. Verify the expiration date; affected products expire on January 31, 2027.
  3. 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.

Key Facts

  • Recall date: November 14, 2025
  • Quantity recalled: 12,576 bottles
  • Health risk due to nitrosamine impurity
  • Contact healthcare providers for guidance

Safety Guide

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 Product

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product TypeCinacalcet Hydrochloride Tablets
Sold At
Multiple Retailers

Product Details

Model Numbers
Lot 5PB0183
exp 1/31/2027
UPC Codes
69097-410
69097-411
69097-412
+3 more
Affected States
ALL
Report Date
December 17, 2025
Source Agency
FDA - Drug Safety
Recall Status
ACTIVE

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