Select lots of the cholesterol‑lowering medication were pulled after testing showed the tablets may not dissolve properly.
AvKARE, Inc. has issued a nationwide Class II recall of specific lots of rosuvastatin calcium tablets after FDA‑regulated testing found the medication does not dissolve properly in the body. The recall affects thousands of 50‑tablet unit‑dose cartons distributed to pharmacies and healthcare facilities across the United States.
The affected batches failed dissolution testing, meaning the tablets may not break down as intended once ingested.
Improper dissolution can reduce how much of the drug is absorbed, potentially limiting its effectiveness for patients managing high cholesterol and cardiovascular risk.
Only AvKARE‑distributed products are included in this recall. No other pharmaceutical companies are affected.
Patients are encouraged to consult their pharmacist or healthcare provider if they believe they received medication from the recalled lots.
The FDA will continue updating its enforcement reports as additional information becomes available.
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