Rosuvastatin Tablets 40mg — Class II drug recall D-0339-2025

Ongoing recall by Glenmark Pharmaceuticals Inc., USA, reported 2025-04-16, distributed nationwide. CGMP Deviations

Recall number	`D-0339-2025`
Product type	Drug
Classification	Class II
Status	Ongoing
Voluntary or mandated	Voluntary
Recalling firm	Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ, United States
Recall initiated	2025-03-13
Classified	2025-04-08
Reported by FDA	2025-04-16
Distributed	Nationwide (US)
Reason classes	cgmp
NDC	`68462-0261`, `68462-0261-01`, `68462-0261-10`, `68462-0261-11`, `68462-0261-30`, `68462-0261-50`, `68462-0261-90`, `68462-0262`, `68462-0262-01`, `68462-0262-10`, `68462-0262-11`, `68462-0262-30`, `68462-0262-50`, `68462-0262-90`, `68462-0263`, `68462-0263-01`, `68462-0263-10`, `68462-0263-11`, `68462-0263-30`, `68462-0263-50`, `68462-0263-90`, `68462-0264`, `68462-0264-01`, `68462-0264-05`, `68462-0264-10` and 3 more
Lot numbers	`17240389`, `17240390`, `17240426`, `17240427`, `17240428`, `17240778`, `17241055`, `17241074`, `17241075`, `17241091`, `17241100`, `APR-26`, `FEB-26`, `JUN-26`, `MAY-26`

Product

Rosuvastatin Tablets 40mg, 30-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-264-30

Reason for recall

CGMP Deviations

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0339-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.