D-0661-2026 Class II Ongoing
FDA drug recall D-0661-2026 was initiated by Cipla USA, Inc. on June 29, 2026 and is designated Class II. Reason for recall: cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI). The recall status is ongoing. Affected quantity: 31,824 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- July 8, 2026
- Initiation Date
- June 29, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 31,824 bottles
Product Description
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 for Recall
cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).
Distribution Pattern
USA Nationwide
Code Information
Lot #: 5PB0465, 5PB0466, 5PB0557, Exp 4/30/2027; 5PB0629, 5PB0630, 5PB0633, 5PB0637, 5PB0638, Exp 6/30/2027