Class III — Low Risk

Low risk — use of or exposure to this product is not likely to cause adverse health consequences.

Levonorgestrel and Ethinyl Estradiol Tablets Recalled by Mylan Pharmaceuticals Inc. Due to Labeling: Not Elsewhere Classified-Incorrect NDC and product name...

Date: August 27, 2018
Company: Mylan Pharmaceuticals 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 Pharmaceuticals Inc. directly.

Affected Products

Levonorgestrel and Ethinyl Estradiol Tablets, USP 0.15 mg/0.03 mg, Rx Only, 3 extended-cycle blister packs containing 91 tablets each, Made in India, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A., NDC 0378-7281-53.

Quantity: 5,790 cartons (526,890 tablets)

Why Was This Recalled?

Labeling: Not Elsewhere Classified-Incorrect NDC and product name identified on blister packs.

Where Was This Sold?

Product was distributed throughout the United States.

About Mylan Pharmaceuticals Inc.

Mylan Pharmaceuticals Inc. has 71 total recalls tracked by RecallDetector.

Related Recalls

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