Drug recall
Cinacalcet Tablets, 30 mg, 30-count bottle, Rx Only, Dr. Reddy's Laboratories Inc, Princeton, NJ 08540, Made…
FDA recall event 95500 · Class II · Dr. Reddy's Laboratories, Inc.
Key facts
| Event ID | 95500 |
|---|---|
| Recall numbers | D-0026-2025, D-0027-2025, D-0028-2025 |
| Recalling firm | Dr. Reddy's Laboratories, Inc. |
| Product type | Drugs |
| Products | Cinacalcet Tablets, 30 mg, 30-count bottle, Rx Only, Dr. Reddy's Laboratories Inc, Princeton, NJ 08540, Made in India, NDC 43598-367-30., Cinacalcet Tablets, 60 mg, 30-count bottles, Rx Only, Dr. Reddy's Laboratories Inc, Princeton, NJ 08540, Made in India, NDC 43598-368-30., Cinacalcet Tablets, 90 mg, 30-count bottle, Rx Only, Dr. Reddy's Laboratories Inc, Princeton, NJ 08540, Made in India., NDC 43598-369-30. |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit |
| Initiation date | Oct 9, 2024 |
| Report date | Nov 6, 2024 |
| City | Princeton |
| State | NJ |
| Country | United States |
| FEI number | 3003989912 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: