FDA DrugsClass II
Cinacalcet Hydrochloride Tablets, 30 mg, 30-count bottle, Rx Only, Manufactured ...
Published: July 8, 2026Recall ID: D-0661-2026Category: drugsCountry: US
Reason for Recall / Hazard
cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).
Product Description & Identification
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
Additional Source Details
| Field | Value |
|---|---|
| City | Warren |
| State | NJ |
| Openfda › Unii | 1K860WSG25 |
| Openfda › Route | ORAL |
| Openfda › Rxcui › 1 | 432400 |
| Openfda › Rxcui › 2 | 432401 |
| Openfda › Rxcui › 3 | 432402 |
| Openfda › Spl id | 383a7dc8-b195-4868-8774-f16a5558771e |
| Openfda › Brand name | CINACALCET |
| Openfda › Spl set id | 02b8c11b-99e8-4039-b6fa-a9c38d2f48fa |
| Openfda › Package ndc › 1 | 69097-410-02 |
| Openfda › Package ndc › 2 | 69097-411-02 |
| Openfda › Package ndc › 3 | 69097-412-02 |
| Openfda › Product ndc › 1 | 69097-410 |
| Openfda › Product ndc › 2 | 69097-411 |
| Openfda › Product ndc › 3 | 69097-412 |
| Openfda › Generic name | CINACALCET |
| Openfda › Product type | HUMAN PRESCRIPTION DRUG |
| Openfda › Substance name | CINACALCET HYDROCHLORIDE |
| Openfda › Manufacturer name | Cipla USA Inc. |
| Openfda › Application number | ANDA208915 |
| Openfda › Is original packager | true |
| Event id | 99350 |
| Address 1 | 10 Independence Blvd |
| Address 2 | N/A |
| Code info | Lot #: 5PB0465, 5PB0466, 5PB0557, Exp 4/30/2027; 5PB0629, 5PB0630, 5PB0633, 5PB0637, 5PB0638, Exp 6/30/2027 |
| Postal code | 07059-2730 |
| Report date | 20260708 |
| Product type | Drugs |
| Product quantity | 31,824 bottles |
| Reason for recall | cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI). |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260629 |
| Initial firm notification | Letter |
| Center classification date | 20260709 |
Overview
- Recalling FirmCipla USA, Inc.
- StatusOngoing
- Risk LevelClass II
- DistributionUSA Nationwide