Colesvelam Hydrocholoride Tablets 625mg — Class II drug recall D-0340-2025
Ongoing recall by Glenmark Pharmaceuticals Inc., USA, reported 2025-04-16, distributed nationwide. CGMP Deviations
| Recall number | D-0340-2025 |
|---|---|
| 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 | 68462-0433, 68462-0433-18, 68462-0433-90 |
| Lot numbers | 17240669, 17240876, 17240883, 17240909, 17240914, 17240927, APR-26, MAR-26, MAY-26 |
Product
Colesvelam Hydrocholoride Tablets 625mg, 180-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-433-18
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-0340-2025. 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.