Colesevelam Hydrochloride Tablets Recalled for CGMP Deviations
Glenmark Pharmaceuticals Inc. is recalling Colesevelam Hydrochloride 625mg tablets nationwide due to CGMP deviations. The firm initiated this Class II voluntary recall; no illnesses or injuries have been reported.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall with no reported illnesses or injuries. The hazard is a manufacturing practice deviation (CGMP) rather than a direct product defect or contamination, and the source text explicitly states no adverse health consequences have occurred.
Plain-English summary
Glenmark Pharmaceuticals Inc., USA is recalling Colesevelam Hydrochloride 625mg tablets in 180-count bottles (NDC# 68462-433-18) distributed nationwide due to Current Good Manufacturing Practice (CGMP) deviations. The affected lots are: 17240669 (expires March 2026), 17240876 (expires April 2026), 17240883 (expires May 2026), 17240909 (expires May 2026), 17240914 (expires May 2026), and 17240927 (expires May 2026).
This is a voluntary, firm-initiated Class II recall. The firm notified FDA by letter on March 13, 2025, and the agency classified the recall on April 8, 2025.
No illnesses or injuries related to this product have been reported. Patients taking Colesevelam Hydrochloride from the affected lots should contact their healthcare provider or pharmacist for guidance. The product is an oral prescription tablet used to help manage cholesterol levels.
The recalled product
- Product
- COLESEVELAM HYDROCHLORIDE (COLESEVELAM HYDROCHLORIDE)
- Brand
- COLESEVELAM HYDROCHLORIDE
- Manufacturer
- Glenmark Pharmaceuticals Inc., USA
- Category
- Drug — Prescription Tablet
- Hazard
- cgmp-deviation
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (7)
- Lot # 17240669
- exp. date Mar-26 17240876
- exp. date Apr-26 17240883
- exp. date May-26 17240909
- exp. date May-26 17240914
- exp. date May-26 17240927
- exp. date May-26
UPCs (1)
- 0368462433188
Distribution
Distributed nationwide across the United States.
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