Colesevelam recalls

The FDA has published 2 recalls involving Colesevelam since 2014. The latest was reported on 16 Apr 2025. Most were for labeling errors. Glenmark Pharmaceuticals Inc., USA has the most recalls in this group. Recalls usually affect specific lots, not every bottle on the market. Check the lot number on each recall page before acting.

Total recalls2since 2014

Last 12 months0reported

Class I00% of total

Ongoing1latest 16 Apr 2025

Recalls per month, last 24 months

click a bar for that month

0Nov '24 0 0 0Feb 0 1 0May 0 0 0Aug 0 0 0Nov 0 0 0Feb 0 0 0May 0 0 0Aug 0 0

Severity split

Class I 0 0%Class II 2 100%Class III 0 0%

Why colesevelam is recalled

Labeling Errors150%
Manufacturing (CGMP) Deviations150%

Companies

Glenmark Pharmaceuticals Inc., USA150%
Aidapak Services150%

By year

2025150%
2014150%

Ongoing colesevelam recalls

1 active

Reported	Class	Recall	Company	Reason	Where
16 Apr 2025Drug	CLASS II	Colesvelam Hydrocholoride Tablets 625mg recalledColesevelam Hydrochloride	Glenmark Pharmaceuticals Inc., USA	Manufacturing (CGMP) Deviations	Nationwide

All colesevelam recalls, newest first

2 total

Reported	Class	Recall	Company	Reason	Where
16 Apr 2025Drug	CLASS II	Colesvelam Hydrocholoride Tablets 625mg recalledColesevelam Hydrochloride	Glenmark Pharmaceuticals Inc., USA	Manufacturing (CGMP) Deviations	Nationwide
22 Jan 2014Drug	CLASS II	Colesevelam HCL Tablet, 625 mg recalled by Aidapak Services	Aidapak Services	Labeling Errors	4 states

Should you stop taking Colesevelam?

Not on your own. Most recalls affect specific lots from one manufacturer, and stopping a prescription suddenly can be riskier than the defect. Check your lot number and NDC against the recall, then call the pharmacy that dispensed it for a replacement.