CLASS II Drug recall · Reported 26 Mar 2025 · FDA Enforcement Report
Cinacalcet Hydrochloride Tablets 60 mg recalled
Slate Run Pharmaceuticals is recalling Cinacalcet Hydrochloride Tablets 60 mg, distributed nationwide in the US. The recall was initiated on 7 Mar 2025 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0279-2025
- FDA event ID
- 96433
- Recalling firm
- Slate Run Pharmaceuticals, Columbus, OH
- Classification
- Class II
- Status
- Completed
- Recall initiated
- 7 Mar 2025
- FDA classified
- 17 Mar 2025
- Reported
- 26 Mar 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Nitrosamine Impurity
Timeline
| 7 Mar 2025 | Recall initiated by company | |
| 17 Mar 2025 | Classified by FDA | +10 days |
| 26 Mar 2025 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP deviations: The presence of nitrosamine impurity above the acceptable daily intake limits.
Nitrosamines are impurities that can form during drug manufacturing or storage. Above the FDA acceptable intake limit, long-term exposure may raise cancer risk. The FDA advises patients to keep taking the medicine until they have a replacement.
Product as listed by the FDA
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
Where it was distributed
Product was distributed to 8 distributors who may have further distribute the product nationwide.
Questions about this recall
Why was it recalled?
CGMP deviations: The presence of nitrosamine impurity above the acceptable daily intake limits.
Which lots are affected?
Lot # 109797, Exp 11/2026
Where was it sold?
Product was distributed to 8 distributors who may have further distribute the product nationwide.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 96433| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Cinacalcet Hydrochloride Tablets 30 mg recalled | Slate Run Pharmaceuticals | Nitrosamine Impurity | Nationwide |
More recalls from Slate Run Pharmaceuticals
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Eptifibatide Injection, 75 mg/ vial recalledEptifibatide | Slate Run Pharmaceuticals | Other | Nationwide |
| Drug | CLASS II | Cinacalcet Hydrochloride Tablets 30 mg recalled | Slate Run Pharmaceuticals | Nitrosamine Impurity | Nationwide |
Other Cinacalcet recalls
All 30| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Cinacalcet Hydrochloride Tablets, 60 mg recalled by Cipla USACinacalcet | Cipla USA | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Cinacalcet Hydrochloride Tablets, 90 mg recalled by Cipla USACinacalcet | Cipla USA | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Cinacalcet Hydrochloride Tablets, 30 mg recalled by Cipla USACinacalcet | Cipla USA | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Sensipar (cinacalcet) Tablets, 30mg recalled by AmgenSensipar | Amgen | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Sensipar (cinacalcet) Tablets, 90mg recalled by AmgenSensipar | Amgen | Manufacturing (CGMP) Deviations | Nationwide |