Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Olmesartan Medoxomil Tablets 20 mg Recalled by Ascend Laboratories LLC Due to cGMP Deviations; Olmesartan Medoximil Tablets 20 mg was...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Ascend Laboratories LLC directly.
Affected Products
Olmesartan Medoxomil Tablets 20 mg, Rx Only, 90 Tablets per Bottle, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013 INDIA, Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054, NDC 67877-446-90.
Quantity: 192 Bottles
Why Was This Recalled?
cGMP Deviations; Olmesartan Medoximil Tablets 20 mg was released in error with alternate API source prior to filing and approval of Prior Approval Supplement.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Ascend Laboratories LLC
Ascend Laboratories LLC has 15 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report