FDAHealthJune 29, 2026
Cipla USA, Inc. — 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,
⚠️ cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- June 29, 2026
USA Nationwide
What's affected?
- 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
- Brand
- CINACALCET
- Lot code
- 5PB0165
Additional details
Lot #: 5PB0165, 5PB0166, Exp 1/31/2027; 5PB0552, Exp 4/30/2027; 5PB0642, 5PB0643, 5PB0644, Exp 6/30/2027
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: N/A.
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