Cinacalcet Tablets recall
FDA recall D-0110-2025 · initiated Nov 27, 2024
AvKARE recalled Cinacalcet Tablets in Nov 2024 — an FDA Class II recall (D-0110-2025) because CGMP deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Cinacalcet above acceptable intake limit.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
CGMP deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Cinacalcet above acceptable intake limit.
An impurity above the accepted limit
A by-product of manufacturing or storage exceeded the limit the FDA accepts. Nitrosamines are the common example: the concern is long-term exposure, not immediate danger from one dose.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 2,796 bottles
Details
- Product
- Cinacalcet Tablets, 90 mg, 30-count bottle, Rx only, Manufactured for: AvKARE, Pulaski, TN 38478, NDC 42291-461-30
- Recalling company
- AvKARE
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- USA Nationwide
- Initiated
- Nov 27, 2024
- FDA report date
- Dec 11, 2024
Frequently asked
- Was Cinacalcet Tablets recalled?
- AvKARE recalled Cinacalcet Tablets in Nov 2024 — an FDA Class II recall (D-0110-2025) because CGMP deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Cinacalcet above acceptable intake limit. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Cinacalcet Tablets recalled?
- Per the FDA enforcement record, the reason for recall D-0110-2025 was: CGMP deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Cinacalcet above acceptable intake limit.
- Is a recalled Cinacalcet Tablets dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Cinacalcet Tablets are affected?
- Distributed: USA Nationwide. The recall covers these lots — Lot #: 44405, Exp 12/31/2024. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0110-2025.