Class II — Potential Health Hazard

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

Mylan Recalled by Mylan LLC. Due to Failed USP Content Uniformity Requirements: OOS result reported...

Date: June 29, 2012
Company: Mylan LLC.
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 LLC. directly.

Affected Products

Mylan, Tacrolimus Capsules 0.5 mg, 100 count bottle, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 NDC 0378-2045-01

Quantity: 15181 bottles.

Why Was This Recalled?

Failed USP Content Uniformity Requirements: OOS result reported on retained samples.

Where Was This Sold?

Natiowide

About Mylan LLC.

Mylan LLC. has 5 total recalls tracked by RecallDetector.

Related Recalls

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