Cinacalcet Tablets recall
FDA recall D-0077-2025 · initiated Nov 7, 2024
Aurobindo Pharma USA Inc recalled Cinacalcet Tablets in Nov 2024 — an FDA Class II recall (D-0077-2025) because cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim 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: 102576 bottles
Details
- Product
- Cinacalcet Tablets, 30 mg, packaged in: a) 30-count HDPE bottle (NDC 65862-831-30); b) 500-count HDPE bottle (NDC 65862-831-05), Rx Only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road, East Windsor, NJ 08520, Made in India.
- Recalling company
- Aurobindo Pharma Limited
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- USA Nationwide
- Initiated
- Nov 7, 2024
- FDA report date
- Dec 11, 2024
Frequently asked
- Was Cinacalcet Tablets recalled?
- Aurobindo Pharma USA Inc recalled Cinacalcet Tablets in Nov 2024 — an FDA Class II recall (D-0077-2025) because cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim 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-0077-2025 was: cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim 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 #: a) CFSA23001A, CFSA23002A, CFSA23003A, Exp 03/31/2025; CFSA23004A, Exp 07/31/2025; CFSA23005A, Exp 10/31/2025; b) P2300191, P2300192, P2300193, P2300194, 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-0077-2025.