AvKARE Recalls Rosuvastatin Tablets Due to Dissolution Issues
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.
Quick Facts at a Glance
Recall Date
March 18, 2026
Hazard Level
MEDIUM
Brands
MAGNESIUM SULFATE, Amneal Pharmaceuticals LLC
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
1 states
At-Risk Groups
GENERAL
Hazard Information
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
What You Should Do
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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Product Details
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.
The Hazard
The tablets do not meet the required specifications for dissolution, potentially affecting their effectiveness. This raises concerns about the medication's safety and efficacy for users.
What to Do
Consumers should immediately stop using the recalled Rosuvastatin Tablets. Contact AvKARE or your healthcare provider for further guidance on the next steps.
Contact Information
For questions regarding the recall, consumers can contact AvKARE directly. Further details are available on their website.
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