MEDIUM

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
December 31, 2025
Hazard Level
MEDIUM
Brands
AvKARE, ROSUVASTATIN
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
1 states
At-Risk Groups
GENERAL

Hazard Information

Out of specification for dissolution.

What You Should Do

Consumers and healthcare providers should stop using this product immediately. Contact AvKARE 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.

Reported Incidents

There are no reported incidents or injuries associated with this recall. Consumers are advised to stop using the product as a precaution.

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.

Key Facts

  • Recall date: December 31, 2025
  • Reported date: January 14, 2026
  • Quantity recalled: 7,991 cartons
  • Product manufactured in Pulaski, TN
  • Lot number: #49124, Expiration: 12/31/2026

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Safety Assessment

Risk LevelMEDIUM
Severity Score
5/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Details

Model Numbers
Lot #49124
Exp Date 12/31/2026
UPC Codes
50268-709
50268-710
50268-711
+6 more
Affected States
ALL
Report Date
January 14, 2026
Source Agency
FDA - Drug Safety
Recall Status
ACTIVE

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