FDA Drug recall D-0449-2026
Cinacalcet Hydrochloride Tablets, 30 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, 30 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-0449-2026 |
| 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, 30 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: 69097-410-02
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: Lot 4PB0526, 4PB0527, 4PB0528, exp September-2026; Lot 5PB0173, 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-0449-2026%22
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