FDA Drug recall D-0450-2026
Cinacalcet Hydrochloride Tablets, 60 mg, 30 Tablets per bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga, India
- FDA Drug
- Class II
- ongoing
- Published 2026-04-22
On 2026-04-22 the FDA classified a Class II recall of Cinacalcet Hydrochloride Tablets, 60 mg, 30 Tablets per bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga, India by Cipla Usa, citing CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0450-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-03-16 |
| Published | 2026-04-22 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Cipla Usa |
| Distribution | US |
Product
Cinacalcet Hydrochloride Tablets, 60 mg, 30 Tablets per bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga, India; Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC: 69097-411-02
Reason
CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit
Identifiers
| ndc | 69097-410-02 |
|---|---|
| ndc | 69097-411-02 |
| ndc | 69097-412-02 |
| code_info | Lot, expiry: 4PB0215, 4PB0216, exp March-2026; 4PB0515, 4PB0516, exp September-2026; 4PB0517, exp September-2026; 5PB0167, exp January-2027 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0450-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.