Cinacalcet Tablets recall
FDA recall D-0031-2025 · initiated Oct 10, 2024
ACCORD HEALTHCARE, INC. recalled Cinacalcet Tablets in Oct 2024 — an FDA Class II recall (D-0031-2025) because CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
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: N/A
Details
- Product
- Cinacalcet Tablets, 60 mg, Rx Only, a) 30 Tablets per bottle, NDC: 16729-441-10, b) 90 Tablets per bottle, NDC: 16729-441-15, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Ahmedabad - 382 210, INDIA.
- Recalling company
- ACCORD HEALTHCARE, INC.
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide in the USA and PR
- Initiated
- Oct 10, 2024
- FDA report date
- Nov 6, 2024
Frequently asked
- Was Cinacalcet Tablets recalled?
- ACCORD HEALTHCARE, INC. recalled Cinacalcet Tablets in Oct 2024 — an FDA Class II recall (D-0031-2025) because CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits. 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-0031-2025 was: CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
- 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: Nationwide in the USA and PR. The recall covers these lots — a) Lot #: Expiry Date: M2204481 02/2025 M2212389 08/2025 M2214271 09/2025 M2215970 10/2025 M2216458 10/2025 b) Lot #: Expiry Date: M2212869 08/2025 M2216362 09/2025 M2215969 10/2025. 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-0031-2025.