Amlodipine and Olmesartan Medoxomil Tablets, 10 mg/20 mg,… was recalled on July 8, 2026 in cooperation with the U.S. Food and Drug Administration because failed Dissolution Specifications; Olmesartan Medoxomil content below specifications.
Amlodipine and Olmesartan Medoxomil Tablets, 10 mg/20 mg, 30 Tablets per bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA; Distributed by: Ascend Laboratories, LLC., Parsnippany, NJ 07054. NDC: 67877-500-30
Lot 25121311, expiry 3/31/2028
Units affected: 6,192 bottles
Where it was sold: Nationwide in the USA
Compare the codes above against the label on your product — usually on the bottom, the back panel, or the packaging. If your unit isn't listed, it is not part of this recall.
Failed Dissolution Specifications; Olmesartan Medoxomil content below specifications
Class II means the product might cause a temporary or medically reversible health problem; the chance of serious harm is remote.
Stop using the product. Return it to the place of purchase for a refund, or dispose of it. Contact the recalling firm with questions.
Contact: Recalling firm: Ascend Laboratories, LLC
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Always confirm details on the official notice from the U.S. Food and Drug Administration before acting.
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