FDA Recall D-0225-2026

Cipla USA, Inc. · Warren, NJ

Class II Ongoing 181 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

Product

Cinacalcet Hydrochloride Tablets, 60 mg, 30 Tablets per bottle, Rx Only, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC: 69097-411-02

Lot / code: Lot 5PB0164, exp 1/31/2027

Quantity: 15,744 bottles

Reason for recall

CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.

Recall record

Recall number: D-0225-2026
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Nationwide in the US
Recall initiated: 2025-11-14
Classified by FDA Center: 2025-12-09
FDA published: 2025-12-17
Recalling firm: Cipla USA, Inc.
Firm location: Warren, NJ

Drug identification

Brand name(s): CINACALCET
Generic name(s): CINACALCET
Manufacturer(s): Cipla USA Inc.
NDC(s): 69097-410, 69097-411, 69097-412
Route(s): ORAL

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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