Cinacalcet Hydrochloride Tablets recall
FDA recall D-0224-2026 · initiated Nov 14, 2025
Cipla USA, Inc. recalled Cinacalcet Hydrochloride Tablets in Nov 2025 — an FDA Class II recall (D-0224-2026) 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: 63,504 bottles
Details
- Product
- 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
- Recalling company
- Cipla Limited
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide in the US
- Initiated
- Nov 14, 2025
- FDA report date
- Dec 17, 2025
Frequently asked
- Was Cinacalcet Hydrochloride Tablets recalled?
- Cipla USA, Inc. recalled Cinacalcet Hydrochloride Tablets in Nov 2025 — an FDA Class II recall (D-0224-2026) 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 Hydrochloride Tablets recalled?
- Per the FDA enforcement record, the reason for recall D-0224-2026 was: CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
- Is a recalled Cinacalcet Hydrochloride 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 Hydrochloride Tablets are affected?
- Distributed: Nationwide in the US. The recall covers these lots — Lot, expiry: Lot 4PB0109, exp 1/31/2026; Lot 5PB0172, exp 1/31/2027. 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-0224-2026.