Ascend Laboratories Recalls Amlodipine and Olmesartan Medoxomil Tablets
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Ascend Laboratories, LLC is recalling 6,192 bottles of Amlodipine and Olmesartan Medoxomil Tablets, 10 mg/20 mg due to failed dissolution specifications.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on August 11, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
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What Happened Ascend Laboratories, LLC initiated a voluntary recall because the product failed dissolution specifications, with Olmesartan Medoxomil content below specifications.
Which Products Are Affected Amlodipine and Olmesartan Medoxomil Tablets, 10 mg/20 mg, 30 Tablets per bottle, Rx Only. NDC: 67877-500-30. Lot 25121311, expiry 3/31/2028. Quantity: 6,192 bottles. Distributed nationwide in the USA. Manufactured by Alkem Laboratories Ltd., INDIA; Distributed by Ascend Laboratories, LLC, Parsippany, NJ 07054. Recall number D-0712-2026.
What You Should Do Consumers with questions should contact the recalling firm or their pharmacist.
Why This Matters This Class II recall involves a prescription blood pressure medication distributed nationwide.
Source FDA Enforcement Report, recall D-0712-2026.
Original source: FDA Official Notice ↗
Related FDA Recalls
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Similar body length
Nearest notices by article body length (831 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to August 11, 2026.
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