Drug recall D-0675-2026
Product
Cinacalcet Hydrochloride Tablets, 60 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 69097-411-02
Reason for recall
cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).
Lots and codes
Lot #: 5PB0165, 5PB0166, Exp 1/31/2027; 5PB0552, Exp 4/30/2027; 5PB0642, 5PB0643, 5PB0644, Exp 6/30/2027
Recall details
- Recalling firm
- Cipla USA, Inc., Warren, NJ
- Quantity
- N/A
- Distribution
- USA Nationwide
- Type
- Voluntary: Firm initiated
- Recall initiated
- June 29, 2026
Related products
- Cinacalcet – drug information
- NDC 69097-410 Cinacalcet · Cinacalcet Hydrochloride 30 mg/1 · Cipla USA Inc.
- NDC 69097-412 Cinacalcet · Cinacalcet Hydrochloride 90 mg/1 · Cipla USA Inc.
- NDC 69097-411 Cinacalcet · Cinacalcet Hydrochloride 60 mg/1 · Cipla USA Inc.