FDA Recall D-0462-2025

Glenmark Pharmaceuticals Inc., USA · Mahwah, NJ

Class III Ongoing 360 days on record

Lower impact — Class III recall — product violates FDA labeling or manufacturing standards but is unlikely to cause adverse health consequences.

Product

Ezetimibe and Simvastatin Tablets, 10mg/40mg, 90-count bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd., Plot No. 2, Phase-2, Pharma Zone SEZ, Madya Pradesh, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, NDC 68462-323-90

Lot / code: Lot #: 17240195, Exp 01/31/2026.

Quantity: 6,759 Con - 90 bottle pack

Reason for recall

Failed Impurities/Degradation Specifications: Out of Specification (OOS) for related substances test for Anhydro Simvastatin at the 06-month time point during long-term stability study.

Recall record

Recall number: D-0462-2025
Classification: Class III
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Nationwide USA and PR
Recall initiated: 2025-05-19
Classified by FDA Center: 2025-06-10
FDA published: 2025-06-18
Recalling firm: Glenmark Pharmaceuticals Inc., USA
Firm location: Mahwah, NJ

Drug identification

Brand name(s): EZETIMIBE AND SIMVASTATIN
Generic name(s): EZETIMIBE AND SIMVASTATIN
Manufacturer(s): Glenmark Pharmaceuticals Inc., USA
NDC(s): 68462-321, 68462-322, 68462-323, 68462-324
Route(s): ORAL

Operational response

Class III recalls are unlikely to cause adverse health consequences but indicate a violation of FDA labeling or manufacturing standards. Pull from active dispensing per your operational policy.

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

‹ All recalls