FDA class II recall: an India-made amlodipine–olmesartan lot failed dissolution testing

The FDA enforcement report lists a class II recall, dated 28 October 2026, of amlodipine and olmesartan medoxomil 10 mg/40 mg tablets manufactured in India by Alkem Laboratories and distributed in the US by Ascend Laboratories. The reason given is an out-of-specification dissolution result. The recall is ongoing.

A dissolution failure means the tablet may not release the drug as intended, which could in principle blunt its effect. A class II recall signals possible temporary or reversible harm rather than serious risk. The action applies to US-distributed product; whether any CDSCO action covers Indian supply is not known from this notice.

• Recheck blood pressure in patients whose control slips without explanation on a fixed-dose combination.
• Ask patients to bring their strips so the brand and batch can be checked.
• Do not stop the antihypertensive on the strength of a recall notice; swap the source if needed.
• The notice covers US-distributed product; Indian lots are not named.

Why it matters

Quality failures in generic combination pills are usually invisible until control drifts.

Don't overread it

A dissolution failure is a manufacturing finding, not a report of patient harm.

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