FDAClass IIApril 16, 2025

Colesvelam Hydrocholoride Tablets 625mg recall: CGMP Deviations

Colesvelam Hydrocholoride Tablets 625mg, 180-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh…

Why was Colesvelam Hydrocholoride Tablets 625mg recalled?

CGMP Deviations

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
Colesvelam Hydrocholoride Tablets 625mg, 180-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh…
Recalling firm
Glenmark Pharmaceuticals Inc., USA
Quantity
N/A
Distribution
U.S. Nationwide
Recall date
April 16, 2025
Classification
Class II
Status
Ongoing
Agency
FDA (drug)
Open FDA enforcement record Latest recalls