Amlodipine and Olmesartan Medoxomil Tablets, 5mg/40mg, Rx… was recalled on May 5, 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, 5mg/40mg, Rx Only, 30-count bottle, Manufactured by: Alkem Laboratories Ltd., India, Distributed by: Ascend Laboratories, LLC., Parsippany, NJ 07054, NDC 67877-501-30.
Lot: 24123460, Expires: October 31, 2027.
Units affected: 15,696 x 30's bottles
Where it was sold: U.S.A. Nationwide
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
Not sure what you're entitled to? Read our guide: what to do if your product is recalled.
Always confirm details on the official notice from the U.S. Food and Drug Administration before acting.
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cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).
cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).
cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).
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