Cinacalcet Hydrochloride Tablets 60 mg recall
FDA recall D-0279-2025 · initiated Mar 7, 2025
Slate Run Pharmaceuticals recalled Cinacalcet Hydrochloride Tablets 60 mg in Mar 2025 — an FDA Class II recall (D-0279-2025) because CGMP deviations: The presence of nitrosamine impurity above the acceptable daily intake limits.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
CGMP deviations: The presence of nitrosamine impurity above the acceptable daily intake 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: 2,444 bottles
Details
- Product
- Cinacalcet Hydrochloride Tablets 60 mg, 30-count bottle, Rx only, Distr. by: Slate Run Pharma., LLC, Columbus, Ohio 43215, Mfg. by: Piramal Pharma Limited, Madhya Pradesh, India, NDC 70436-008-04
- Recalling company
- Slate Run Pharma
- Classification
- Class II
- Status
- Completed
- Type
- Voluntary: Firm initiated
- Distribution
- Product was distributed to 8 distributors who may have further distribute the product nationwide.
- Initiated
- Mar 7, 2025
- FDA report date
- Mar 26, 2025
Frequently asked
- Was Cinacalcet Hydrochloride Tablets 60 mg recalled?
- Slate Run Pharmaceuticals recalled Cinacalcet Hydrochloride Tablets 60 mg in Mar 2025 — an FDA Class II recall (D-0279-2025) because CGMP deviations: The presence of nitrosamine impurity above the acceptable daily intake limits. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Cinacalcet Hydrochloride Tablets 60 mg recalled?
- Per the FDA enforcement record, the reason for recall D-0279-2025 was: CGMP deviations: The presence of nitrosamine impurity above the acceptable daily intake limits.
- Is a recalled Cinacalcet Hydrochloride Tablets 60 mg 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 60 mg are affected?
- Distributed: Product was distributed to 8 distributors who may have further distribute the product nationwide.. The recall covers these lots — Lot # 109797, Exp 11/2026. 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-0279-2025.