FDA Drug recall D-0661-2026
Cinacalcet Hydrochloride Tablets, 30 mg, 30-count bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga, India
- FDA Drug
- Class II
- ongoing
- Published 2026-07-08
On 2026-07-08 the FDA classified a Class II recall of Cinacalcet Hydrochloride Tablets, 30 mg, 30-count bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga, India by Cipla Usa, citing cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0661-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-06-29 |
| Published | 2026-07-08 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Cipla Usa |
| Distribution | US |
Product
Cinacalcet Hydrochloride Tablets, 30 mg, 30-count 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 of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).
Identifiers
| ndc | 69097-410-02 |
|---|---|
| ndc | 69097-411-02 |
| ndc | 69097-412-02 |
| code_info | Lot #: 5PB0465, 5PB0466, 5PB0557, Exp 4/30/2027; 5PB0629, 5PB0630, 5PB0633, 5PB0637, 5PB0638, Exp 6/30/2027 |
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-0661-2026%22
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