FDA Recall D-0079-2025

Aurobindo Pharma USA Inc · East Windsor, NJ

Class II Ongoing 553 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 Tablets, 90 mg, packaged in: a) 30-count HDPE bottle (NDC 65862-833-30), b) 500-count HDPE bottle (NDC 65862-833-05), Rx Only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road, East Windsor, NJ 08520, Made in India. 90 mg - 30 Tablets - NDC 65862-833-30 90 mg - 500 Tablets - NDC 65862-833-05

Lot / code: Lot #: a) CFSC23001A, CFSC23001B, Exp 03/31/2025; b) P2300195, Exp 12/31/2024

Reason for recall

cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit

Recall record

Recall number: D-0079-2025
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: USA Nationwide
Recall initiated: 2024-11-07
Classified by FDA Center: 2024-11-29
FDA published: 2024-12-11
Recalling firm: Aurobindo Pharma USA Inc
Firm location: East Windsor, NJ

Drug identification

Brand name(s): CINACALCET
Generic name(s): CINACALCET
Manufacturer(s): Aurobindo Pharma Limited
NDC(s): 65862-831, 65862-832, 65862-833
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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