Class II โ€” Potential Health Hazard

Potential health hazard โ€” use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Mycophenolic Acid Delayed-release Tablets Recalled by Mylan Lab Inc Due to Failed Dissolution Specifications: Low out of specification dissolution...

Date: May 20, 2015
Company: Mylan Lab Inc
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Mylan Lab Inc directly.

Affected Products

Mycophenolic Acid Delayed-release Tablets, 180 mg, 120-count bottle, Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A., NDC 0378-4201-78, UPC 3 0378-4201-78 7.

Quantity: 7,722 bottles

Why Was This Recalled?

Failed Dissolution Specifications: Low out of specification dissolution results.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Mylan Lab Inc

Mylan Lab Inc has 1 total recall tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report