FDA recall: a blood-pressure combination tablet failing dissolution specifications — a tablet that does not dissolve is not absorbed, however much it contains (Ascend Laboratories)
A combination tablet of amlodipine and olmesartan medoxomil was recalled for failing dissolution specifications and for olmesartan medoxomil content below specification. The quantity is 6,192 bottles, distributed nationwide.
Recall overview (primary data)
- ClassificationClass II
- Product typeDrug
- Recalling firmAscend Laboratories, LLC
- ReasonFailed Dissolution Specifications; Olmesartan Medoxomil content below specifications
- DistributionNationwide in the USA
- Recall initiated2026-07-08
Key points
- A combination tablet of amlodipine and olmesartan medoxomil was recalled for failing dissolution specifications and for content below specification.
- A dissolution test measures how quickly a tablet releases its contents; a different profile changes how much reaches the bloodstream and when.
- Manufactured by Alkem Laboratories in India and distributed by Ascend Laboratories; 6,192 bottles distributed nationwide.
- Blood-pressure medicines are taken daily, and a decline in effect is not necessarily something a person can feel.
- Of the 1,408 records this site holds as of 2026-08-31, 9 touch on dissolution, against 36 citing subpotency, 12 out-of-specification and 37 foreign matter or precipitate.
1If it does not dissolve, it does not arrive
A dissolution test measures how quickly a tablet releases its contents in the body. For a swallowed medicine to work, the active ingredient has to dissolve and be absorbed. Even where a tablet contains the specified amount, a different dissolution profile changes how much reaches the bloodstream and when.
This record cites both a failed dissolution specification and a shortfall in the ingredient itself, so a problem of quantity and a problem of release are occurring at the same time.
2That it is a blood-pressure medicine
The product combines a calcium channel blocker and an angiotensin II receptor blocker. Blood-pressure medicines are taken daily over long periods, and a decline in effect is not necessarily something a person can feel. It shows up as a number at the next measurement, and until then a state of taking the medicine without the pressure coming down can persist.
A combination tablet reduces missed doses by putting two ingredients in one, but when one ingredient has a problem the whole tablet falls within scope.
3Dissolution appears in 9 of 1,408 records
Sorting the 1,408 FDA recall records this site holds as of 2026-08-31 by the wording of their reasons, only 9 touch on dissolution. That is fewer than the 36 citing subpotency, the 12 citing out-of-specification results, or the 37 citing foreign matter or precipitate.
Dissolution measures whether a product becomes usable in the body, separately from whether the ingredient is present, and it depends on both formulation design and manufacturing process. Whether the small count means the problem rarely arises or that opportunities to detect it are limited cannot be determined from the records.
Why it matters
Containing the specified amount of an active ingredient and becoming usable in the body are separate requirements. Dissolution depends on formulation design as well as manufacturing process, and is not guaranteed by the quality of the drug substance alone. For medicines taken continuously, a decline in effect stays invisible to patient and clinician alike until the next measurement.
FAQ
What is a dissolution test?
How do content shortfall and dissolution failure differ?
Would someone taking it notice?
Sources (primary)
Source: openFDA (U.S. FDA, CC0 public domain). Data is provided as-is and must not be used for medical decisions. Verify the latest and exact details with the official FDA recall information. This site is not endorsed or certified by the U.S. FDA.
- FDA recall information (official)
- openFDA (data provider)
- Recall number: D-0712-2026