Quick Facts at a Glance
- Recall Date
- May 22, 2026
- Hazard Level
- MEDIUM
- Brand
- SUN PHARMACEUTICAL INDUSTRIES
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Drug Safety; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- SUN PHARMACEUTICAL INDUSTRIES
- Product type
- Rosuvastatin Tablets
- Model numbers
- Lot #: AE11393, Exp Date: 10/2027.
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
May 22, 2026
Reported by FDA DRUG
June 10, 2026
RecallRadar source check
June 17, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Labeling: Not Elsewhere Classified. This recall has been initiated in response to the denial by FDA of marketing the product under the proprietary name Xyvona
What You Should Do
Consumers and healthcare providers should stop using this product immediately. Contact SUN PHARMACEUTICAL INDUSTRIES INC or your healthcare provider for guidance. Notification method: Letter
About This Product
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.
Why This Is Dangerous
The dissolution issue means the tablets may not release the active ingredient as intended, potentially reducing effectiveness and safety.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Consumers are advised to stop using the product immediately, which may cause inconvenience for those relying on the medication for cholesterol management.
Practical Guidance
How to identify if yours is affected
- Check the carton for the lot number #49124.
- Verify the expiration date on the packaging: 12/31/2026.
- Confirm that the product matches the description of the recalled Rosuvastatin Tablets.
Where to find product info
Look for the lot number and expiration date printed on the carton and individual tablet packaging.
What timeline to expect
Expect a refund or replacement process to take approximately 4-6 weeks after returning the product.
If the manufacturer is unresponsive
- Document all interactions with AvKARE regarding the recall.
- Consider reaching out again via different contact methods.
- File a complaint with the FDA if necessary.
How to prevent similar issues
- When purchasing medications, check for FDA recalls online.
- Always verify the expiration dates and lot numbers of prescription medications.
- Consult your healthcare provider if unsure about the safety of a medication.
Documentation advice
Keep records of purchase receipts, correspondence with the manufacturer, and any notes on side effects experienced.
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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.
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 Guide
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