D-0224-2026 Class II Ongoing
FDA drug recall D-0224-2026 was initiated by Cipla USA, Inc. on Nov 14, 2025 and is designated Class II. Reason for recall: CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits. The recall status is ongoing. Affected quantity: 63,504 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- Dec 17, 2025
- Initiation Date
- Nov 14, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 63,504 bottles
Product Description
Cinacalcet Hydrochloride Tablets, 30 mg, 30 Tablets per bottle, Rx Only, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC: 69097-410-02
Reason for Recall
CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
Distribution Pattern
Nationwide in the US
Code Information
Lot, expiry: Lot 4PB0109, exp 1/31/2026; Lot 5PB0172, exp 1/31/2027
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0224-2026
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026