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.

Temozolomide Capsules Recalled by Mylan LLC. Due to Failed Tablet/Capsule Specifications: customer complaints of broken or...

Date: December 20, 2016
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

Temozolomide Capsules, 100 mg, packaged in a) 5-count bottles (NDC 0378-5262-98), b) 14-count bottles (NDC 0378-5262-14), Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 USA.

Quantity: a) 574 bottles (lot 2006895) and 495 bottles (lot 2006896); b) 744 bottles (lot 2006895)

Why Was This Recalled?

Failed Tablet/Capsule Specifications: customer complaints of broken or crushed capsules, resulting in loose powder in the bottle.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

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