FDA Recall D-0001-2025

Nivagen Pharmaceuticals Inc · Sacramento, CA

Class II Ongoing 597 days on record

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

Product

Atorvastatin Calcium Tablets, USP, 40mg, Rx only, 1000 Tablets per bottle, Manufactured for: Nivagen Pharmaceuticals, Inc. Sacramento, CA 95827, USA, Manufactured by: Umedica Laboratories Pvt Ltd., Vapi Gujarat 396195, India, NDC: 75834-257-01.

Lot / code: Lot #: U24T0408A, Exp: 03/31/2026

Quantity: 2328 bottles

Reason for recall

Presence of Foreign Tablets/Capsules: A Carbamazepine Extended-Release 400 mg tablet was found in a 1000-count bottle of Atorvastatin Calcium Tablets, USP 40 mg.

Recall record

Recall number: D-0001-2025
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: E-Mail
Distribution: Nationwide within the U.S
Recall initiated: 2024-09-24
Classified by FDA Center: 2024-10-02
FDA published: 2024-10-09
Recalling firm: Nivagen Pharmaceuticals Inc
Firm location: Sacramento, CA

Drug identification

Brand name(s): ATORVASTATIN CALCIUM
Generic name(s): ATORVASTATIN CALCIUM
Manufacturer(s): NIVAGEN PHARMACEUTICALS, INC.
NDC(s): 75834-255, 75834-256, 75834-257, 75834-258
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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