FDA Recall D-0218-2026

Cipla USA, Inc. · Warren, NJ

Class II Ongoing 202 days on record

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

Product

Lanthanum Carbonate chewable tablets, 1000mg*, 10x9 bottles per patient pack carton, Rx Only, Manufactured by: Invagen Pharmaceuticals, Inc., (a subsidary of Cipla Ltd) Hauppauge, NY 11786, Manufactured for: Exelan Pharmaceuticals, Inc., Boca Raton, FL 33422, Carton NDC 76282-478-90; Bottle NDC 76282-478-13.

Lot / code: Lot# NB240314, exp 12/31/2025

Quantity: N/A

Reason for recall

Failed stability specifications: Out of specification for hardness test

Recall record

Recall number: D-0218-2026
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: N/A
Distribution: Nationwide in the USA
Recall initiated: 2025-10-24
Classified by FDA Center: 2025-12-05
FDA published: 2025-12-17
Recalling firm: Cipla USA, Inc.
Firm location: Warren, NJ

Drug identification

Brand name(s): LANTHANUM CARBONATE
Generic name(s): LANTHANUM CARBONATE
Manufacturer(s): Exelan Pharmaceuticals, Inc.
NDC(s): 76282-476, 76282-477, 76282-478
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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