The FDA enforcement report lists a class II recall, dated 28 October 2026, of cinacalcet 30 mg tablets manufactured in India by Strides Pharma Science and distributed in the US. The reason given is failure to meet dissolution specifications. The recall is ongoing.
A dissolution failure means the tablet may release less drug than intended, which in principle could blunt control of parathyroid hormone. The notice covers US-distributed product; whether any action applies to supply in India is not known from this record.
- Recheck PTH and calcium if control slips unexpectedly on generic cinacalcet.
- Note the brand and batch when a patient's response changes.
- Do not stop cinacalcet on the basis of a recall notice; switch source if needed.
- The notice applies to US-distributed product.
Why it matters
Generic quality failures are invisible until biochemistry drifts.
Don't overread it
A dissolution failure is a manufacturing finding, not a report of patient harm.
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