Amlodipine and Olmesartan Medoxomil Tablets Recall
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
Ascend Laboratories, LLC is voluntarily recalling one lot of Amlodipine and Olmesartan Medoxomil Tablets, 5mg/40mg due to failed dissolution specifications.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on July 9, 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.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, Drugs.
What Happened
Ascend Laboratories, LLC initiated a voluntary recall of Amlodipine and Olmesartan Medoxomil Tablets after the product failed dissolution specifications, with Olmesartan Medoxomil content below specifications.
Which Products Are Affected
The recall affects Amlodipine and Olmesartan Medoxomil Tablets, 5mg/40mg, Rx Only, 30-count bottles (NDC 67877-501-30). A total of 15,696 bottles are involved, distributed nationwide in the United States. The affected lot is 24123460, expiring October 31, 2027. The product was manufactured by Alkem Laboratories Ltd., India and distributed by Ascend Laboratories, LLC, Parsippany, NJ.
What You Should Do
Consumers should stop using the affected product and contact their physician or pharmacist. For return or refund information, contact Ascend Laboratories, LLC.
Why This Matters
The recall involves a widely distributed prescription medication for blood pressure management that does not meet dissolution specifications.
Source
FDA recall number D-0556-2026, Class II, event ID 98874.
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (1,058 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to July 9, 2026.
Frequently Asked Questions
Common questions about this FDA recall.