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
April 28, 2026
Hazard Level
MEDIUM
Brands
LACTATED RINGERS, B. Braun Medical Inc.
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
1 states
At-Risk Groups
GENERAL

Hazard Information

Presence of Particulate Matter.

What You Should Do

Consumers and healthcare providers should stop using this product immediately. Contact B BRAUN MEDICAL INC or your healthcare provider for guidance. Notification method: Press Release

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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

  1. Check the carton for the lot number #49124.
  2. Verify the expiration date on the packaging: 12/31/2026.
  3. 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.

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

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: What to Do When You Find a Recalled Product

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Safety Assessment

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

Product Details

Model Numbers
Lot #:J4P756
J4S843
Exp 5/31/2027
UPC Codes
0264-7750
0264-7750-07
Affected States
ALL
Report Date
May 13, 2026
Source Agency
FDA - Drug Safety
Recall Status
ACTIVE

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