D-0450-2026 Class II Ongoing
FDA drug recall D-0450-2026 was initiated by Cipla USA, Inc. on Mar 16, 2026 and is designated Class II. Reason for recall: CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit The recall status is ongoing. Affected quantity: 96,096 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- Apr 22, 2026
- Initiation Date
- Mar 16, 2026
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 96,096 bottles
Product Description
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 for Recall
CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit
Distribution Pattern
Nationwide in the USA
Code Information
Lot, expiry: 4PB0215, 4PB0216, exp March-2026; 4PB0515, 4PB0516, exp September-2026; 4PB0517, exp September-2026; 5PB0167, exp January-2027
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0450-2026
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026