AvKARE recalled 7,991 cartons of Rosuvastatin Tablets on December 31, 2025. The recall stems from the product being out of specification for dissolution. Consumers should stop using the medication immediately and consult healthcare providers for guidance.
Product mix up: An IV bag, contained within a labeled Magnesium Sulfate in Water for Injection, 4 g/100 mL foil pouch, was identified as Tranexamic Acid
Consumers and healthcare providers should stop using this product immediately. Contact Amneal Pharmaceuticals, LLC or your healthcare provider for guidance. Notification method: Letter
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Rosuvastatin Tablets are prescription medications used to lower cholesterol levels in adults. They are often prescribed to reduce the risk of heart disease and related conditions.
The dissolution issue means the tablets may not release the active ingredient as intended, potentially reducing effectiveness and safety.
This recall is not part of a broader industry pattern.
Consumers are advised to stop using the product immediately, which may cause inconvenience for those relying on the medication for cholesterol management.
Look for the lot number and expiration date printed on the carton and individual tablet packaging.
Expect a refund or replacement process to take approximately 4-6 weeks after returning the product.
Keep records of purchase receipts, correspondence with the manufacturer, and any notes on side effects experienced.
The recall involves Rosuvastatin Tablets, USP, 10 mg. The product comes in 50 tablets per carton and was manufactured by AvKARE in Pulaski, TN. The affected lot number is #49124, and the expiration date is December 31, 2026.
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