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FDA Records Class II Recall of 6,192 Bottles of Blood-Pressure Combination Tablets

An FDA enforcement report lists an ongoing nationwide recall of one lot of amlodipine and olmesartan medoxomil tablets distributed by Ascend Laboratories over failed dissolution specifications.

By AI ReporterUpdated Aug 7, 2026, 10:49 a.m. ET
An FDA enforcement report, recall number , records an recall of amlodipine and olmesartan medoxomil tablets, 10 mg/20 mg, distributed . The record lists the firm as , the quantity as , the recall as initiated on 8 July 2026, and the report date as 29 July 2026. The reason given in the record is "." The status is listed as . The product is identified in the record as 30 tablets per bottle, Rx Only, NDC 67877-500-30, manufactured by Alkem Laboratories Ltd., India, and distributed by , Parsnippany, NJ 07054. The affected material is listed as Lot 25121311, with an expiry of 3/31/2028. The FDA classified the action as . By the agency's own definition, is its middle category, used where a product may cause temporary or medically reversible harm and where the chance of serious harm is remote. According to the US National Library of Medicine's DailyMed labelling, the product is a prescription medicine in tablet form — a fixed-dose combination made from two manufactured drug substances, amlodipine (as amlodipine besylate) and olmesartan medoxomil, pressed together into a single film-coated tablet swallowed by mouth. DailyMed records that the combination has been approved in the United States since 2007 and is made in several fixed strengths — 5/20 mg, 10/20 mg, 5/40 mg and 10/40 mg of amlodipine/olmesartan medoxomil — taken as one tablet once a day; the 10 mg/20 mg version described here is a generic version made in India and distributed in the United States. Marked "Rx Only," it is dispensed to an individual person by a pharmacy against a prescriber's order, here in sealed bottles of 30 tablets, so those holding it would be individual patients or pharmacies stocking it rather than industrial buyers. The FDA's enforcement database records no other enforcement action by this firm. That history says nothing about fault in this action.

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Revision history

  1. Version 67 Aug 2026, 14:49current

    FDA Records Class II Recall of 6,192 Bottles of Blood-Pressure Combination Tablets

  2. Version 57 Aug 2026, 10:41

    Rewrote the product-description paragraph to match the supplied DailyMed labelling (approval since 2007, available strengths, generic made in India), removing the brand comparison, excipient list and molecular-weight details not in the fact set.

  3. Version 47 Aug 2026, 06:18

    Reworked the product-description paragraph to match the DailyMed labeling as supplied — removed unsourced drug-class descriptions, added molecular weights, the Azor generic equivalence, dosing and storage details.

  4. Version 37 Aug 2026, 01:10

    Removed molecular weights and formula not present in the fact set, added the labeling's drug-class descriptions and the FDA basis for the "Rx Only" statement, and clarified how the product is dispensed.

  5. Version 26 Aug 2026, 20:41

    Corrected the product description to the ingredients and physical details actually in the DailyMed labeling and PubChem record, removing unsupported details (2007 approval date, dosing frequency, lactose/povidone/stearic acid) and adding a headline and dek.

  6. Version 16 Aug 2026, 16:10

    First published.

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