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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

Rosuvastatin Tablets Recalled Due to Dissolution Issues

Agency Publication Date: January 7, 2026
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Summary

AvKARE is recalling approximately 7,991 cartons of Rosuvastatin Tablets (10 mg), a prescription medication used to treat high cholesterol. The recall was initiated because the tablets failed to meet required dissolution specifications, which means they may not dissolve properly in the body. If the drug does not dissolve as intended, it may not be absorbed correctly, potentially reducing its effectiveness in managing cholesterol levels.

Risk

The failure of the tablets to dissolve according to specifications can lead to lower-than-expected levels of the medication in the patient's bloodstream, which may result in poor control of cholesterol and related cardiovascular health issues.

What You Should Do

  1. Check your medication packaging for Rosuvastatin Tablets, USP, 10 mg (50-count cartons) with NDC 50268-709-15, Lot #49124, and an expiration date of 12/31/2026.
  2. If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.
  3. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 1: Full Refund
How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund
๐Ÿ—‘๏ธOption 2: Dispose of Product
How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Rosuvastatin Tablets, USP, 10 mgby AvKARE
Variants: 10 mg, Tablet
Lot Numbers:
49124 (Exp 12/31/2026)
NDC:
50268-709-15

Rx Only; 50 Tablets (5 x 10) Unit Dose per carton

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 98246
Status: Active
Manufacturer: AvKARE
Sold By: Pharmacies
Manufactured In: United States
Units Affected: 7,991 5x10 cartons
Distributed To: Nationwide
Agency Last Updated: January 20, 2026

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.