Glenmark Pharmaceuticals recalls 625mg Colesvelam Hydrochloride tablets due to CGMP deviations. Affected lots manufactured in India for US distribution. No specific remedy stated in recall notice.
CGMP Deviations
Glenmark Pharmaceuticals is recalling 625mg Colesvelam Hydrochloride tablets (180-count) that were manufactured in India for US distribution. The recall is due to CGMP deviations, which means the product may not meet quality standards. This recall does not include a specific remedy or action for consumers.
CGMP deviations refer to failures in the manufacturing process that could affect product quality. This means the tablets might not be safe or effective as intended. However, the recall does not specify what harm could result from using these tablets.
People with a prescription for Colesvelam Hydrochloride 625mg tablets who received this specific lot from Glenmark Pharmaceuticals Inc. in the US. Those with the NDC number 68462-433-18 are most at risk.
Check for the NDC number 68462-433-18 on the product label. The product was manufactured in India and distributed in the US under the brand name Colesvelam Hydrochloride 625mg tablets.
Look for the NDC number 68462-433-18 on the tablet packaging.
The recall notice does not state any remedy or action for consumers.
The recall is due to CGMP deviations, which means the product may not meet quality standards. The exact risk is not specified in the notice.
Check for the NDC number 68462-433-18 on the product label. The product was manufactured in India and distributed in the US.
We’ve drafted a message you can send Glenmark to request your refund or repair — edit it as you like.
Subject: Recall D-0340-2025 — Glenmark Glenmark Hello, I own a Glenmark that is covered by recall D-0340-2025 from Glenmark. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
