RECALL DATABASE

Amlodipine and Olmesartan Medoxomil Recall: Ascend Lot 25120696

Announced 2026-10-28 · FDA

This recall involves Amlodipine and Olmesartan Medoxomil Tablets, 10 mg/40 mg, 30-tablet bottles (Rx only) distributed nationwide. The product is out of specification due to dissolution. Lot 25120696 with expiration 12/31/2026 includes 11,424 bottles.

BrandAscend Laboratories, LLC
ProductAmlodipine and Olmesartan Medoxomil Tablets, 10mg/40mg, 30 Tablets, Rx only, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-502-30.
ReasonOut of specification due to dissolution.
Severitymoderate
Units affected11424
DistributionNationwide within the United States
AgencyFDA

WHAT YOU SHOULD DO

  1. Do not use any tablets from Lot 25120696.
  2. Check your bottle's lot number and expiration date; contact your pharmacy or healthcare provider for guidance and a replacement or refund.
  3. If you have used this product and have concerns or experience symptoms, contact your clinician and report adverse effects to the FDA.

How to identify the recalled item

Lot / date codesLot # 25120696, Exp Date: December 31, 2026.
Lot / date codesLot # 25120696, Exp Date: December 31, 2026.

These are the identifiers FDA published for this recall. Most recall notices list no UPC or model number at all — if the code on your item is not shown here, that does not mean the item is excluded. Check the official notice, or contact the company.

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This is an automatically maintained record of an official recall notice. Details can change; always follow the official notice linked above. See all records in the Recall Database.