Cinacalcet Hydrochloride Manufacturing Recall
Cinacalcet Hydrochloride Tablets, 30 mg, , , Inc., 10 Ind has been recalled due to cgmp deviations: the presence of a nitrosamine impurity, n-nitroso-cinacalcet, above the acceptable daily intake (adi) limits.. Patients taking this medication should consult their pharmacist or doctor.
By RecallRadar Editorial Team
Sourced from FDA. Last verified March 4, 2026.
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Check if you qualifyKey facts
- Date announced
- November 14, 2025
- Source agency
- FDA
This recall involves safety concerns. Take action promptly.
✨ Plain-English Summary
Cinacalcet Hydrochloride Tablets, 30 mg, , , Inc., 10 Ind has been recalled due to cgmp deviations: the presence of a nitrosamine impurity, n-nitroso-cinacalcet, above the acceptable daily intake (adi) limits.. Patients taking this medication should consult their pharmacist or doctor.
Is This Recall Still Active?
Status: Yes - Active
This recall is currently active. If your device matches the affected models, follow the official instructions as soon as possible.
What's Being Recalled
Quoted source excerpt from the official notice.
CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
Quick Info
Key facts from the official notice, kept in the article flow for easy cross-checking.
- Brand
- Cipla usa
- Category
- drug
- Source agency
- FDA
- Announced
- November 14, 2025
- Country
- US
- Status
- Active
Who's Affected
Specific models and identifiers listed in the source notice:
Model #1
Lot, expiry: Lot 4PB0109, exp 1/31/2026; Lot 5PB0172, exp 1/31/2027
| # | Model |
|---|---|
| 1 | Lot, expiry: Lot 4PB0109, exp 1/31/2026; Lot 5PB0172, exp 1/31/2027 |
Technical model codes are manufacturer identifiers. Match both the product name and model code from your device settings, label, or packaging.
What You Should Do
Follow the remedy path from the official notice using the exact model and serial details above.
- 1## Cinacalcet Hydrochloride Tablets, 30 mg, 30 Tablets per bottle, Rx Only, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ
- 2NDC: 69097-410-02 Agency: FDA | Category: drug Reason: CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits. What to do:
- 3Stop using the product if your lot/model matches.
- 4Check the FDA notice for specifics.
Source & Verification
This page summarizes the official notice and keeps key facts easy to verify.
- Official source
- FDA
- Announced by source
- November 14, 2025
- Last reviewed by RecallRadar
- March 4, 2026
Frequently Asked Questions
Am I affected by this recall?
Check the affected models section on this page. The official notice currently lists Lot, expiry: Lot 4PB0109, exp 1/31/2026; Lot 5PB0172, exp 1/31/2027.
What is the remedy for this recall?
## Cinacalcet Hydrochloride Tablets, 30 mg, 30 Tablets per bottle, Rx Only, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC: 69097-410-02 Agency: FDA | Category: drug Reason: CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits. What to do: 1. Stop using the product if your lot/model matches. 2. Check the FDA notice for specifics. 3. Follow remedy instructions.
Where can I verify recall details?
Use the official source link in this page to confirm dates, eligibility, and next steps: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts
Keep browsing with these internal hubs: Cipla USA recall hub and Food & Drug recall hub.
Official Resources
Use these primary sources for final eligibility and claim instructions.
View official notice from FDASee an inaccuracy?
Help us improve the accuracy of this recall information.
On this page
Free checker
Check if you qualify
See whether your device may qualify for a free repair or replacement program before you spend money.
Check if you qualifyKey facts
- Date announced
- November 14, 2025
- Source agency
- FDA
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