AvKARE Cinacalcet Tablets Recall: Nitrosamine Impurity Risk
AvKARE recalls 60mg Cinacalcet tablets due to nitrosamine impurity exceeding safety limits. This medication, prescribed for high calcium levels, may pose health risks if taken.
Recall notice
CGMP deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Cinacalcet above acceptable intake limit.
Contact the company
What happened, in plain English
AvKARE is recalling 60mg Cinacalcet tablets (30-count bottles) that contain a nitrosamine impurity above safe levels. This could pose health risks to patients taking the medication as prescribed. Read more at govinfonow.com/recall/32391-avkare-cinacalcet-tablets-recall-nitrosamine-impurity-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/32391-avkare-cinacalcet-tablets-recall-nitrosamine-impurity-risk · Updated September 23, 2026 · FDA enforcement record: FDA #D-0109-2025
Cite this page
“AvKARE Cinacalcet Tablets Recall: Nitrosamine Impurity Risk.” GovInfoNow, updated September 23, 2026. https://govinfonow.com/recall/32391-avkare-cinacalcet-tablets-recall-nitrosamine-impurity-risk. Based on FDA recall #D-0109-2025 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0109-2025%22&limit=1).
Why it’s dangerous
The tablets contain a nitrosamine impurity (N-Nitroso-Cinacalcet) that exceeds acceptable safety limits. This impurity could potentially cause health issues when taken by patients.
Who’s affected
Patients prescribed Cinacalcet tablets for high calcium levels are affected. Those using the medication as directed are most at risk.
How to tell if you have this one
Check for the 60mg Cinacalcet tablets in 30-count bottles with NDC 42291-460-30. The lot number is 44550, expiring December 31, 2024.
- Brand
AvKARE- Category
Drug
All 3 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Ongoing- Distribution
USA Nationwide
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-0108-2025 | Cinacalcet Tablets, 30 mg, 30-count bottle, Rx only, Manufactured for: AvKARE, Pulaski, TN 38478, NDC 42291-459-30; Lot#: 44378, 44597, 45804, Exp 12/31/2024 | 50,304 bottles |
| D-0109-2025 | Cinacalcet Tablets, 60 mg, 30-count bottle, Rx only, Manufactured for: AvKARE, Pulaski, TN 38478, NDC 42291-460-30; Lot # 44550, Exp 12/31/2024 | 2,396 bottles |
| D-0110-2025 | Cinacalcet Tablets, 90 mg, 30-count bottle, Rx only, Manufactured for: AvKARE, Pulaski, TN 38478, NDC 42291-461-30; Lot #: 44405, Exp 12/31/2024 | 2,796 bottles |
What to do — step by step
Check Medication Details
Verify the product label shows Cinacalcet 60mg, 30-count bottle, NDC 42291-460-30, and lot number 44550.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “USA Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 14 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
Similar recalls
Other AvKARE recalls
Latest drug recalls
Keep exploring
Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0109-2025 (November 27, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0109-2025 to see it in context.
- Plain-language summary written by qwen3:4b on September 23, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.